%PDF-1.4
%âãÏÓ
1 0 obj
<<
/Type /Pages
/Count 2
/Kids [ 4 0 R 12 0 R ]
>>
endobj
2 0 obj
<<
/Type /Catalog
/OpenAction 16 0 R
/Pages 1 0 R
/Metadata 18 0 R
>>
endobj
3 0 obj
<<
/CreationDate (D:20020710101119Z)
/Producer (PDFlib 2.01 \(c\) 1997-99 Thomas Merz)
/ModDate (D:20031201135547-05'00')
>>
endobj
4 0 obj
<<
/Type /Page
/Parent 1 0 R
/Resources 11 0 R
/MediaBox [ 0 0 612 792 ]
/Contents [ 5 0 R ]
>>
endobj
5 0 obj
<< /Length 6 0 R >>
stream
0 G
1 w
20 20 572 752 re
S
0 G
1 w
306 538 m
306 772 l
S
0 G
1 w
20 680 m
592 680 l
S
0 G
1 w
306 752 m
592 752 l
S
0 G
1 w
480 680 m
480 650 l
S
0 G
1 w
20 650 m
592 650 l
S
0 G
1 w
20 583 m
592 583 l
S
0 G
1 w
20 538 m
592 538 l
S
0 G
1 w
175 583 m
175 538 l
S
BT
/F0 7 Tf
7 TL
0 g
0 G
/F0 7 Tf
7 TL
1 0 0 1 71.47 755 Tm
(DEPARTMENT OF HEALTH AND HUMAN SERVICES)Tj
/F1 7 Tf
7 TL
0 g
0 G
/F1 7 Tf
7 TL
1 0 0 1 114.2 745 Tm
(PUBLIC HEALTH SERVICE)Tj
0 g
0 G
/F1 7 Tf
7 TL
1 0 0 1 97.33 735 Tm
(FOOD AND DRUG ADMINISTRATION)Tj
/F0 10 Tf
10 TL
0 g
0 G
/F0 10 Tf
10 TL
1 0 0 1 81.89 715 Tm
(DECLARATION FOR IMPORTED)Tj
0 g
0 G
/F0 10 Tf
10 TL
1 0 0 1 63 705 Tm
(ELECTRONIC PRODUCTS SUBJECT TO)Tj
0 g
0 G
/F0 10 Tf
10 TL
1 0 0 1 71.34 695 Tm
(RADIATION CONTROL STANDARDS)Tj
/F2 7 Tf
7 TL
0 g
0 G
/F2 7 Tf
7 TL
1 0 0 1 315 764 Tm
(Form Approved OMB No. 0910-0025)Tj
0 g
0 G
/F2 7 Tf
7 TL
1 0 0 1 315 756 Tm
(Expiration Date: 11/30/2003)Tj
/F0 7 Tf
7 TL
0 g
0 G
/F0 7 Tf
7 TL
1 0 0 1 427.8 742 Tm
(INSTRUCTIONS)Tj
/F1 7 Tf
7 TL
0 g
0 G
/F1 7 Tf
7 TL
1 0 0 1 315 732 Tm
(1. If submitting entries electronically through ACS/ABI, hold FDA-2877 in)Tj
0 g
0 G
/F1 7 Tf
7 TL
1 0 0 1 325 724 Tm
(entry file. Do not submit to FDA unless requested.)Tj
0 g
0 G
/F1 7 Tf
7 TL
1 0 0 1 315 716 Tm
(2. If submitting paper entry documents, submit the following to FDA:)Tj
0 g
0 G
/F1 7 Tf
7 TL
1 0 0 1 330 708 Tm
(a. 2 copies of Customs Entry Form \(e.g. CF 3461, CF 3461 Alt,)Tj
0 g
0 G
/F1 7 Tf
7 TL
1 0 0 1 340 700 Tm
(CF 7501, etc.\))Tj
0 g
0 G
/F1 7 Tf
7 TL
1 0 0 1 330 692 Tm
(b. 1 copy of FDA 2877)Tj
0 g
0 G
/F1 7 Tf
7 TL
1 0 0 1 330 684 Tm
(c. Commercial Invoice\(s\) in English.)Tj
/F1 8 Tf
8 TL
0 g
0 G
/F1 8 Tf
8 TL
1 0 0 1 24 672 Tm
(U.S. CUSTOMS PORT OF ENTRY)Tj
0 g
0 G
/F1 8 Tf
8 TL
1 0 0 1 310 672 Tm
(ENTRY NUMBER)Tj
0 g
0 G
/F1 8 Tf
8 TL
1 0 0 1 484 672 Tm
(DATE OF ENTRY)Tj
0 g
0 G
/F1 8 Tf
8 TL
1 0 0 1 24 642 Tm
(NAME & ADDRESS OF MANUFACTURING SITE; COUNTRY OF ORIGIN)Tj
0 g
0 G
/F1 8 Tf
8 TL
1 0 0 1 310 642 Tm
(NAME & ADDRESS OF IMPORTER & ULTIMATE CONSIGNEE)Tj
/F2 7 Tf
7 TL
0 g
0 G
/F2 7 Tf
7 TL
1 0 0 1 542 643 Tm
(\(if not importer\))Tj
/F1 8 Tf
8 TL
0 g
0 G
/F1 8 Tf
8 TL
1 0 0 1 24 575 Tm
(PRODUCT DESCRIPTION)Tj
0 g
0 G
/F1 8 Tf
8 TL
1 0 0 1 179 575 Tm
(QUANTITY)Tj
/F2 7 Tf
7 TL
0 g
0 G
/F2 7 Tf
7 TL
1 0 0 1 223 576 Tm
(\(Items/Containers\))Tj
/F1 8 Tf
8 TL
0 g
0 G
/F1 8 Tf
8 TL
1 0 0 1 310 575 Tm
(MODEL NUMBER\(S\) & BRAND NAME\(S\))Tj
0 G
1 w
ET
20 527 m
592 527 l
S
BT
/F0 7 Tf
7 TL
0 g
0 G
/F0 7 Tf
7 TL
1 0 0 1 30 530 Tm
(DECLARATION: I / WE DECLARE THAT THE PRODUCTS IDENTIFIED ABOVE:)Tj
/F3 8 Tf
8 TL
0 g
0 G
/F3 8 Tf
8 TL
1 0 0 1 305 530 Tm
(\(Mark X applicable statements, fill in blanks, & sign\))Tj
/F0 8 Tf
8 TL
0 G
1 w
ET
25 522 8 -8 re
S
0 g
0 G
BT
/F0 8 Tf
8 TL
1 0 0 1 37 515 Tm
(A. ARE NOT SUBJECT TO RADIATION PERFORMANCE STANDARDS BECAUSE THEY:)Tj
/F1 7 Tf
7 TL
0 G
1 w
ET
37 510 8 -8 re
S
0 g
0 G
BT
/F1 7 Tf
7 TL
1 0 0 1 49 503 Tm
(1. Were manufactured prior to the effective date of any applicable standard; Date of Manufacture __________________________ .)Tj
0 G
1 w
ET
37 498 8 -8 re
S
0 g
0 G
BT
/F1 7 Tf
7 TL
1 0 0 1 49 491 Tm
(2. Are excluded by the applicability clause or definition in the standard or by FDA written guidance.)Tj
0 g
0 G
/F1 7 Tf
7 TL
1 0 0 1 65 479 Tm
(Specify reason for exclusion _______________________________________________.)Tj
0 G
1 w
ET
37 474 8 -8 re
S
0 g
0 G
BT
/F1 7 Tf
7 TL
1 0 0 1 49 467 Tm
(3. Are personal household goods of an individual entering the U.S. or being returned to a U.S. resident. \(Limit: 3 of each product type\).)Tj
0 G
1 w
ET
37 462 8 -8 re
S
0 g
0 G
BT
/F1 7 Tf
7 TL
1 0 0 1 49 455 Tm
(4. Are property of a party residing outside the U.S. and will be returned to the owner after repair or servicing.)Tj
0 G
1 w
ET
37 450 8 -8 re
S
0 g
0 G
BT
/F1 7 Tf
7 TL
1 0 0 1 49 443 Tm
(5. Are components or subassemblies to be used in manufacturing or as replacement parts \(NOT APPLICABLE to diagnostic x-ray parts\).)Tj
0 G
1 w
ET
37 438 8 -8 re
S
0 g
0 G
BT
/F1 7 Tf
7 TL
1 0 0 1 49 431 Tm
(6. Are prototypes intended for on going product development by the importing firm, are labeled "FOR TEST/EVALUATION ONLY," and will be exported,)Tj
0 g
0 G
/F1 7 Tf
7 TL
1 0 0 1 59 419 Tm
(destroyed, or held for future testing \(i.e., not distributed\). \(Quantities Limited - see reverse.\))Tj
0 G
1 w
ET
37 414 8 -8 re
S
0 g
0 G
BT
/F1 7 Tf
7 TL
1 0 0 1 49 407 Tm
(7. Are being reprocessed in accordance with P.L. 104-134 or other FDA guidance, are labeled "FOR EXPORT ONLY," and will not be sold, distributed,)Tj
0 g
0 G
/F1 7 Tf
7 TL
1 0 0 1 59 395 Tm
(or transferred without FDA approval.)Tj
/F0 8 Tf
8 TL
0 G
1 w
ET
25 386 8 -8 re
S
0 g
0 G
BT
/F0 8 Tf
8 TL
1 0 0 1 37 379 Tm
(B. COMPLY WITH THE PERFORMANCE STANDARDS)Tj
/F1 8 Tf
8 TL
0 g
0 G
/F1 8 Tf
8 TL
1 0 0 1 245 379 Tm
(WHICH ARE APPLICABLE AT DATE OF MANUFACTURE AND THAT A)Tj
0 g
0 G
/F1 8 Tf
8 TL
1 0 0 1 50 369 Tm
(CERTIFICATION LABEL OR TAG TO THIS EFFECT IS AFFIXED TO EACH PRODUCT. COMPLIANCE DOCUMENTED IN:)Tj
/F1 7 Tf
7 TL
0 G
1 w
ET
37 364 8 -8 re
S
0 g
0 G
BT
/F1 7 Tf
7 TL
1 0 0 1 49 357 Tm
(1. Last annual report or Product/Initial report)Tj
0 g
0 G
/F1 7 Tf
7 TL
1 0 0 1 81 345 Tm
(_____________________________)Tj
0 g
0 G
/F1 7 Tf
7 TL
1 0 0 1 84 335 Tm
(ACCESSION NUMBER of Report)Tj
0 g
0 G
/F1 7 Tf
7 TL
1 0 0 1 210 345 Tm
(_____________________________________________________________)Tj
0 g
0 G
/F1 7 Tf
7 TL
1 0 0 1 214 335 Tm
(Name of MANUFACTURER OF RECORD)Tj
/F2 7 Tf
7 TL
0 g
0 G
/F2 7 Tf
7 TL
1 0 0 1 348 336 Tm
(\(Filed report with FDA/CDRH\))Tj
0 G
1 w
ET
37 325 8 -8 re
S
BT
/F1 7 Tf
7 TL
0 g
0 G
/F1 7 Tf
7 TL
1 0 0 1 49 318 Tm
(2. Unknown manufacturer or report number; State reason: _____________________________________________________________)Tj
/F0 8 Tf
8 TL
0 G
1 w
ET
25 304 8 -8 re
S
0 g
0 G
BT
/F0 8 Tf
8 TL
1 0 0 1 37 297 Tm
(C. DO NOT COMPLY WITH PERFORMANCE STANDARDS;)Tj
/F1 8 Tf
8 TL
0 g
0 G
/F1 8 Tf
8 TL
1 0 0 1 265 297 Tm
(ARE BEING HELD UNDER A TEMPORARY IMPORT BOND; WILL NOT)Tj
0 g
0 G
/F1 8 Tf
8 TL
1 0 0 1 50 287 Tm
(BE INTRODUCED INTO COMMERCE; WILL BE USED UNDER A RADIATION PROTECTION PLAN; AND WILL BE DESTROYED)Tj
0 g
0 G
/F1 8 Tf
8 TL
1 0 0 1 50 277 Tm
(OR EXPORTED UNDER U.S. CUSTOMS SUPERVISION WHEN THE FOLLOWING MISSION IS COMPLETE:)Tj
/F1 7 Tf
7 TL
0 G
1 w
ET
37 272 8 -8 re
S
0 g
0 G
BT
/F1 7 Tf
7 TL
1 0 0 1 49 265 Tm
(1. Research, Investigations/Studies, or Training \(attach Form FDA 766\))Tj
0 G
1 w
ET
37 260 8 -8 re
S
0 g
0 G
BT
/F1 7 Tf
7 TL
1 0 0 1 49 253 Tm
(2. Trade Show/Demonstration; List dates & use restrictions ______________________________________________________________)Tj
/F0 8 Tf
8 TL
0 G
1 w
ET
25 241 8 -8 re
S
0 g
0 G
BT
/F0 8 Tf
8 TL
1 0 0 1 37 234 Tm
(D. DO NOT COMPLY WITH PERFORMANCE STANDARDS;)Tj
/F1 8 Tf
8 TL
0 g
0 G
/F1 8 Tf
8 TL
1 0 0 1 265 234 Tm
(ARE HELD AND WILL REMAIN UNDER BOND; AND WILL NOT BE)Tj
0 g
0 G
/F1 8 Tf
8 TL
1 0 0 1 50 224 Tm
(INTRODUCED INTO COMMERCE UNTIL NOTIFICATION IS RECEIVED FROM FDA THAT PRODUCTS HAVE BEEN BROUGHT)Tj
0 g
0 G
/F1 8 Tf
8 TL
1 0 0 1 50 214 Tm
(INTO COMPLIANCE IN ACCORDANCE WITH AN FDA APPROVED PETITION.)Tj
/F2 8 Tf
8 TL
0 g
0 G
/F2 8 Tf
8 TL
1 0 0 1 340 214 Tm
(\(See Form FDA 766.\))Tj
/F1 7 Tf
7 TL
0 G
1 w
ET
37 207 8 -8 re
S
0 g
0 G
BT
/F1 7 Tf
7 TL
1 0 0 1 49 200 Tm
(1. Approved Petition is attached.)Tj
0 G
1 w
ET
180 207 8 -8 re
S
0 g
0 G
BT
/F1 7 Tf
7 TL
1 0 0 1 192 200 Tm
(2. Petition Request is attached.)Tj
0 G
1 w
ET
325 207 8 -8 re
S
0 g
0 G
BT
/F1 7 Tf
7 TL
1 0 0 1 337 200 Tm
( 3. Request will be submitted within 60 days.)Tj
0 G
1 w
ET
20 190 m
592 190 l
S
0 G
1 w
20 114 m
592 114 l
S
0 G
1 w
240 190 m
240 114 l
S
0 G
1 w
240 151 m
592 151 l
S
BT
/F0 7 Tf
7 TL
0 g
0 G
/F0 7 Tf
7 TL
1 0 0 1 30 180 Tm
(WARNING: Any person who knowingly makes a false)Tj
0 g
0 G
/F0 7 Tf
7 TL
1 0 0 1 30 170 Tm
(declaration may be fined not more than $10,000 or)Tj
0 g
0 G
/F0 7 Tf
7 TL
1 0 0 1 30 160 Tm
(imprisoned not more than 5 years or both, pursuant to Title)Tj
0 g
0 G
/F0 7 Tf
7 TL
1 0 0 1 30 150 Tm
(18 U.S.C. 1001. Any person importing a non- compliant)Tj
0 g
0 G
/F0 7 Tf
7 TL
1 0 0 1 30 140 Tm
(electronic product may also be subject to civil penalties of)Tj
0 g
0 G
/F0 7 Tf
7 TL
1 0 0 1 30 130 Tm
($1000 per violation, up to a maximum $300,000 for related)Tj
0 g
0 G
/F0 7 Tf
7 TL
1 0 0 1 30 120 Tm
(violations pursuant to Title 21 U.S.C. 360pp.)Tj
/F1 8 Tf
8 TL
0 g
0 G
/F1 8 Tf
8 TL
1 0 0 1 245 182 Tm
(SIGNATURE OF IMPORTER OF RECORD)Tj
0 g
0 G
/F1 8 Tf
8 TL
1 0 0 1 245 143 Tm
(NAME AND TITLE OF RESPONSIBLE PERSON)Tj
/F0 7 Tf
7 TL
0 g
0 G
/F0 7 Tf
7 TL
1 0 0 1 30 104 Tm
(Public reporting burden for this collection of information)Tj
/F1 7 Tf
7 TL
0 g
0 G
/F1 7 Tf
7 TL
1 0 0 1 222 104 Tm
(is estimated to average 0.2 hour per response, including the time for reviewing instructions,)Tj
0 g
0 G
/F1 7 Tf
7 TL
1 0 0 1 30 94 Tm
(searching existing data sources, gathering and maintaining the data needed, and completing reviewing the collection of information. Send comments regarding)Tj
0 g
0 G
/F1 7 Tf
7 TL
1 0 0 1 30 84 Tm
(this burden estimate or any other aspect of this collection of information, including suggestions for reducing this burden to:)Tj
0 g
0 G
/F1 7 Tf
7 TL
1 0 0 1 125 70 Tm
(Food and Drug Administration)Tj
0 g
0 G
/F1 7 Tf
7 TL
1 0 0 1 125 60 Tm
(CDRH \(HFZ-342\))Tj
0 g
0 G
/F1 7 Tf
7 TL
1 0 0 1 125 50 Tm
(2094 Gaither Road)Tj
0 g
0 G
/F1 7 Tf
7 TL
1 0 0 1 125 40 Tm
(Rockville, MD 20850)Tj
/F2 7 Tf
7 TL
0 g
0 G
/F2 7 Tf
7 TL
1 0 0 1 75.44 27 Tm
(An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number.)Tj
/F0 8 Tf
8 TL
0 g
0 G
/F0 8 Tf
8 TL
1 0 0 1 20 12 Tm
(FORM FDA 2877 \(12/00\))Tj
/F1 8 Tf
8 TL
0 g
0 G
/F1 8 Tf
8 TL
1 0 0 1 245.4 12 Tm
(PREVIOUS EDITION IS OBSOLETE)Tj
/F1 5 Tf
5 TL
0 g
0 G
/F1 5 Tf
5 TL
1 0 0 1 390 13 Tm
(Created by: PSC Media Arts \(301\) 443-2454)Tj
/F1 8 Tf
8 TL
0 g
0 G
/F1 8 Tf
8 TL
1 0 0 1 497 12 Tm
(PAGE 1 OF 2 PAGES)Tj
/F1 5 Tf
5 TL
0 g
0 G
/F1 5 Tf
5 TL
1 0 0 1 585 13 Tm
(EF)Tj
ET
endstream
endobj
6 0 obj
10211
endobj
7 0 obj
<<
/Type /Font
/Subtype /Type1
/Name /F0
/Encoding /WinAnsiEncoding
/BaseFont /Helvetica-Bold
>>
endobj
8 0 obj
<<
/Type /Font
/Subtype /Type1
/Name /F1
/Encoding /WinAnsiEncoding
/BaseFont /Helvetica
>>
endobj
9 0 obj
<<
/Type /Font
/Subtype /Type1
/Name /F2
/Encoding /WinAnsiEncoding
/BaseFont /Times-Italic
>>
endobj
10 0 obj
<<
/Type /Font
/Subtype /Type1
/Name /F3
/Encoding /WinAnsiEncoding
/BaseFont /Times-BoldItalic
>>
endobj
11 0 obj
<<
/ProcSet [ /PDF /Text ]
/Font << /F0 7 0 R /F1 8 0 R /F2 9 0 R /F3 10 0 R >>
>>
endobj
12 0 obj
<<
/Type /Page
/Parent 1 0 R
/Resources 15 0 R
/MediaBox [ 0 0 612 792 ]
/Contents [ 13 0 R ]
>>
endobj
13 0 obj
<< /Length 14 0 R >>
stream
0 G
1 w
20 20 572 752 re
S
BT
/F0 10 Tf
10 TL
0 g
0 G
/F0 10 Tf
10 TL
1 0 0 1 136 762 Tm
(INSTRUCTIONS TO IMPORTERS/BROKERS OF ELECTRONIC PRODUCTS)Tj
/F0 9 Tf
9 TL
0 g
0 G
/F0 9 Tf
9 TL
1 0 0 1 40 745 Tm
(PURPOSE:)Tj
/F1 9 Tf
9 TL
0 g
0 G
/F1 9 Tf
9 TL
1 0 0 1 90 745 Tm
(The Form FDA 2877 must be completed for electronic products subject to Radiation Control Standards \(21 CFR 1010)Tj
0 g
0 G
/F1 9 Tf
9 TL
1 0 0 1 40 735 Tm
(and 1020-1050\) prior to entry into the United States. The local Food and Drug Administration \(FDA\) district office will review the)Tj
0 g
0 G
/F1 9 Tf
9 TL
1 0 0 1 40 725 Tm
(declaration and notify the importer/agent if the products may be released into U.S. commerce or if they must be held under bond until)Tj
0 g
0 G
/F1 9 Tf
9 TL
1 0 0 1 40 715 Tm
(exported, destroyed, or reconditioned. Until the shipment is released, it may be subject to redelivery for FDA examination.)Tj
/F0 9 Tf
9 TL
0 g
0 G
/F0 9 Tf
9 TL
1 0 0 1 40 695 Tm
(PAPER OR ELECTRONIC SUBMISSION:)Tj
/F1 9 Tf
9 TL
0 g
0 G
/F1 9 Tf
9 TL
1 0 0 1 215 695 Tm
(Paper entries may be made by submitting the signed original FDA 2877 along with U.S.)Tj
0 g
0 G
/F1 9 Tf
9 TL
1 0 0 1 40 685 Tm
(Customs forms to the local FDA district office; if electronic products are given a MAY PROCEED, a signed copy of CF 3461 will be)Tj
0 g
0 G
/F1 9 Tf
9 TL
1 0 0 1 40 675 Tm
(returned, or if not given a MAY PROCEED, a FDA Notice of Action will be issued. For electronic entries, follow U.S. Customs Service)Tj
0 g
0 G
/F1 9 Tf
9 TL
1 0 0 1 40 665 Tm
(ACS/ABI format and procedures, supported by a signed copy of this form or similar letter. Multiple entries of the same product and)Tj
0 g
0 G
/F1 9 Tf
9 TL
1 0 0 1 40 655 Tm
(model families that are filed electronically may be supported by one form dated not more than 12 months previously.)Tj
/F0 9 Tf
9 TL
0 g
0 G
/F0 9 Tf
9 TL
1 0 0 1 40 635 Tm
(DECLARATION:)Tj
/F1 9 Tf
9 TL
0 g
0 G
/F1 9 Tf
9 TL
1 0 0 1 115 635 Tm
(Select A, B, C, or D and then select the appropriate number; fill in requested information and sign. For electronic)Tj
0 g
0 G
/F1 9 Tf
9 TL
1 0 0 1 40 625 Tm
(entries, AofC \(affirmation of compliance\) = RA#, RB#, RC# or RD# \(e.g., Radiation Declaration A5 = RA5\).)Tj
/F0 9 Tf
9 TL
0 g
0 G
/F0 9 Tf
9 TL
1 0 0 1 475 625 Tm
(Transmit model number)Tj
0 g
0 G
/F0 9 Tf
9 TL
1 0 0 1 40 615 Tm
(using AofC code MDL and transmit brand name using FDA line level brand name field. If RA3 or RA6 is selected, you must)Tj
0 g
0 G
/F0 9 Tf
9 TL
1 0 0 1 40 605 Tm
(transmit quantity \(number of units\) using the Quantity and Unit of Measure Pairs at the FDA line level.)Tj
/F0 9 Tf
9 TL
0 g
0 G
/F0 9 Tf
9 TL
1 0 0 1 58 585 Tm
(DECLARATION A:)Tj
/F1 9 Tf
9 TL
0 g
0 G
/F1 9 Tf
9 TL
1 0 0 1 145 585 Tm
(Importers should be prepared to demonstrate compliance to or non-applicability of FDA standards,)Tj
0 g
0 G
/F1 9 Tf
9 TL
1 0 0 1 40 575 Tm
(regulations, or guidance. Components or sub-assemblies must be non-functioning. Products being reprocessed must be exported by)Tj
0 g
0 G
/F1 9 Tf
9 TL
1 0 0 1 40 565 Tm
(the importer, without intermediate transfer of ownership. For RA3 the quantity limit is 3 and for RA6 the limit = 50 units TV products,)Tj
0 g
0 G
/F1 9 Tf
9 TL
1 0 0 1 40 555 Tm
(microwave ovens, and Class 1 laser products limit = 200 units CD-ROM and DVD \(digital versatile disc\) laser products; see May 14,)Tj
0 g
0 G
/F1 9 Tf
9 TL
1 0 0 1 40 545 Tm
(1997, notice to industry issued by the Center for Devices and Radiological Health \(CDRH\).)Tj
/F0 9 Tf
9 TL
0 g
0 G
/F0 9 Tf
9 TL
1 0 0 1 58 525 Tm
(DECLARATION B:)Tj
/F1 9 Tf
9 TL
0 g
0 G
/F1 9 Tf
9 TL
1 0 0 1 145 525 Tm
(If declaration RB1 is selected, provide the FDA Establishment Identifier \(FEI\) of the manufacturer who filed)Tj
0 g
0 G
/F1 9 Tf
9 TL
1 0 0 1 40 515 Tm
(the radiation product/abbreviated report to FDA, CDRH, Rockville, Maryland. To transmit the accession number of that report use AofC)Tj
0 g
0 G
/F1 9 Tf
9 TL
1 0 0 1 40 505 Tm
(code ACC. If the manufacturer cannot be determined or located, the importer must be able to provide evidence showing a certification)Tj
0 g
0 G
/F1 9 Tf
9 TL
1 0 0 1 40 495 Tm
(\(certifi.\) label on each product and state reason: returned to orig exporter or certifi. label evidence. The new AofC codes \(RB1, RB2\))Tj
0 g
0 G
/F1 9 Tf
9 TL
1 0 0 1 40 485 Tm
(for this declaration will not be activated until a process is made available to determine the FEI of the responsible firm. Continue to use)Tj
0 g
0 G
/F1 9 Tf
9 TL
1 0 0 1 40 475 Tm
(RAB in electronic transmission until the FEI query is available and industry is notified of its availability.)Tj
/F0 9 Tf
9 TL
0 g
0 G
/F0 9 Tf
9 TL
1 0 0 1 58 455 Tm
(DECLARATION C:)Tj
/F1 9 Tf
9 TL
0 g
0 G
/F1 9 Tf
9 TL
1 0 0 1 145 455 Tm
(Noncompliant products may be imported only for research, investigations/studies, demonstration or training.)Tj
0 g
0 G
/F1 9 Tf
9 TL
1 0 0 1 40 445 Tm
(They should be used only by trained personnel and under controlled conditions to avoid unnecessary radiation exposure. Product\(s\))Tj
0 g
0 G
/F1 9 Tf
9 TL
1 0 0 1 40 435 Tm
(will be detained by the local FDA district office. Since product\(s\) for which "C" Declarations are made will be under Temporary Import)Tj
0 g
0 G
/F1 9 Tf
9 TL
1 0 0 1 40 425 Tm
(Bond \(TIB\) or equivalent, ultimate disposition is limited to export or destruction under U.S. Customs supervision when the purpose has)Tj
0 g
0 G
/F1 9 Tf
9 TL
1 0 0 1 40 415 Tm
(been achieved or the length of time stated has expired. For purposes other than demonstration, the Form FDA 766, outlining)Tj
0 g
0 G
/F1 9 Tf
9 TL
1 0 0 1 40 405 Tm
(protections, must be approved by FDA prior to use. The importer/broker must include with the FDA 766:)Tj
0 g
0 G
/F1 9 Tf
9 TL
1 0 0 1 58 385 Tm
(1. A full description of the subject electronic product\(s\).)Tj
0 g
0 G
/F1 9 Tf
9 TL
1 0 0 1 58 375 Tm
(2. The purpose for which the product\(s\) is being imported.)Tj
0 g
0 G
/F1 9 Tf
9 TL
1 0 0 1 58 365 Tm
(3. How the product\(s\) will be used.)Tj
0 g
0 G
/F1 9 Tf
9 TL
1 0 0 1 58 355 Tm
(4. Where the product\(s\) will be located.)Tj
0 g
0 G
/F1 9 Tf
9 TL
1 0 0 1 58 345 Tm
(5. The approximate length of time and dates the product\(s\) will be in this country.)Tj
0 g
0 G
/F1 9 Tf
9 TL
1 0 0 1 40 325 Tm
(For product\(s\) being used for trade shows/demonstrations, list the dates and use restrictions \(Form FDA 766 is not required\). A sign)Tj
0 g
0 G
/F1 9 Tf
9 TL
1 0 0 1 40 315 Tm
(stating that the product does not comply with FDA performance standards must be displayed and viewable at all times during the use)Tj
0 g
0 G
/F1 9 Tf
9 TL
1 0 0 1 40 305 Tm
(of product\(s\). All medical products, cabinet x-ray, or Class lllb and IV lasers may NOT operate \(turn on product\(s\)\) at trade shows.)Tj
/F0 9 Tf
9 TL
0 g
0 G
/F0 9 Tf
9 TL
1 0 0 1 58 285 Tm
(DECLARATION D:)Tj
/F1 9 Tf
9 TL
0 g
0 G
/F1 9 Tf
9 TL
1 0 0 1 145 285 Tm
(Noncompliant products must be brought into compliance with standards under FDA supervision and)Tj
0 g
0 G
/F1 9 Tf
9 TL
1 0 0 1 40 275 Tm
(following a plan approved by FDA. The plan, documented on the Form FDA 766, must address technical requirements, labeling, and)Tj
0 g
0 G
/F1 9 Tf
9 TL
1 0 0 1 40 265 Tm
(reporting. Some plans may need approval by both the CDRH and the local FDA district office. Use of this declaration is limited to)Tj
0 g
0 G
/F1 9 Tf
9 TL
1 0 0 1 40 255 Tm
(occasional shipments; ongoing reconditioning is considered manufacturing that is handled through other means. Product\(s\) will be)Tj
0 g
0 G
/F1 9 Tf
9 TL
1 0 0 1 40 245 Tm
(detained by the local FDA district office. An FDA 766 must be filed indicating the procedure intended to bring the product into)Tj
0 g
0 G
/F1 9 Tf
9 TL
1 0 0 1 40 235 Tm
(compliance. This procedure will include a satisfactory corrective action plan and/or a product report. The FDA 766 must include all of)Tj
0 g
0 G
/F1 9 Tf
9 TL
1 0 0 1 40 225 Tm
(the information requested under Declaration C. The approximate length of time will be for the amount of time needed to bring)Tj
0 g
0 G
/F1 9 Tf
9 TL
1 0 0 1 40 215 Tm
(product\(s\) into compliance. Declaration D is also made for failure to provide reports, failure to certify, etc.)Tj
/F1 9 Tf
9 TL
0 g
0 G
/F1 9 Tf
9 TL
1 0 0 1 40 195 Tm
(If an importer/broker intends to import equipment into the United States for purposes of research, investigation, studies,)Tj
0 g
0 G
/F1 9 Tf
9 TL
1 0 0 1 40 185 Tm
(demonstrations, or training but also wishes to retain the option of bringing the product into compliance with the performance standard,)Tj
0 g
0 G
/F1 9 Tf
9 TL
1 0 0 1 40 175 Tm
(check Declarations C and D on the FDA 2877 and insert the word "or" between the Affirmations. Note: The U.S. Customs Service will)Tj
0 g
0 G
/F1 9 Tf
9 TL
1 0 0 1 40 165 Tm
(treat this entry as a "D" Declaration for purposes of duty. Such requests must be made on the FDA 766; include Items 1, 2, and 3)Tj
0 g
0 G
/F1 9 Tf
9 TL
1 0 0 1 40 155 Tm
(under Declaration C, a statement of the need to use the option "C" or "D" Declaration, a statement of how the product\(s\) will be)Tj
0 g
0 G
/F1 9 Tf
9 TL
1 0 0 1 40 145 Tm
(brought into compliance and the approximate length of time necessary to evaluate or demonstrate the product\(s\) and the time)Tj
0 g
0 G
/F1 9 Tf
9 TL
1 0 0 1 40 135 Tm
(necessary to bring the product\(s\) into compliance \(both actions must be accomplished within the period of time granted by FDA\). For)Tj
0 g
0 G
/F1 9 Tf
9 TL
1 0 0 1 40 125 Tm
(electronic entries select Declaration RD3.)Tj
/F1 9 Tf
9 TL
0 g
0 G
/F1 9 Tf
9 TL
1 0 0 1 40 105 Tm
(Ultimately, product\(s\) must be brought into compliance with the applicable standard in accordance with a corrective action plan which)Tj
0 g
0 G
/F1 9 Tf
9 TL
1 0 0 1 40 95 Tm
(has been approved by the FDA. If the product\(s\) are not brought into compliance within the allotted time frame of the approved)Tj
0 g
0 G
/F1 9 Tf
9 TL
1 0 0 1 40 85 Tm
(application and an extension is not requested of, or granted by, the FDA, the local FDA district office shall refuse entry on the shipment)Tj
0 g
0 G
/F1 9 Tf
9 TL
1 0 0 1 40 75 Tm
(and require the product\(s\) to be either exported or destroyed under U.S. Customs supervision.)Tj
/F1 9 Tf
9 TL
0 g
0 G
/F1 9 Tf
9 TL
1 0 0 1 40 55 Tm
(If additional guidance is needed, please contact your local FDA district office or consult the following FDA web pages:)Tj
0 g
0 G
/F1 9 Tf
9 TL
1 0 0 1 40 45 Tm
(www.fda.gov/cdrh, www.fda.gov/ora/hier/ora_field_names.txt, and www.fda.gov/ora/compliance_ref/rpm_new2/contens.html)Tj
/F1 9 Tf
9 TL
0 g
0 G
/F1 9 Tf
9 TL
1 0 0 1 40 25 Tm
([Re: 21 U.S.C. 360mm, 21 CFR 1005, 19 CFR 12.90-12.91.] FDA: CP 7382.007/.007A)Tj
/F0 8 Tf
8 TL
0 g
0 G
/F0 8 Tf
8 TL
1 0 0 1 20 12 Tm
(FORM FDA 2877 \(12/00\))Tj
/F1 8 Tf
8 TL
0 g
0 G
/F1 8 Tf
8 TL
1 0 0 1 245.4 12 Tm
(PREVIOUS EDITION IS OBSOLETE)Tj
/F1 8 Tf
8 TL
0 g
0 G
/F1 8 Tf
8 TL
1 0 0 1 497 12 Tm
(PAGE 2 OF 2 PAGES)Tj
ET
endstream
endobj
14 0 obj
11144
endobj
15 0 obj
<<
/ProcSet [ /PDF /Text ]
/Font << /F0 7 0 R /F1 8 0 R >>
>>
endobj
16 0 obj
[
4 0 R /Fit
]
endobj
18 0 obj
<< /Type /Metadata /Subtype /XML /Length 827 >>
stream
2002-07-10T10:11:19Z
PDFlib 2.01 (c) 1997-99 Thomas Merz
2003-12-01T13:55:47-05:00
2002-07-10T10:11:19Z
2003-12-01T13:55:47-05:00
2003-12-01T13:55:47-05:00
endstream
endobj
xref
0 19
0000000017 65535 f
0000000016 00000 n
0000000087 00000 n
0000000178 00000 n
0000000320 00000 n
0000000438 00000 n
0000010703 00000 n
0000010725 00000 n
0000010844 00000 n
0000010958 00000 n
0000011075 00000 n
0000011197 00000 n
0000011300 00000 n
0000011420 00000 n
0000022620 00000 n
0000022643 00000 n
0000022725 00000 n
0000000000 00001 f
0000022758 00000 n
trailer
<<
/Size 19
/Info 3 0 R
/Root 2 0 R
/ID[]
>>
startxref
23669
%%EOF