THIS IS A VISUAL DESIGN FILE ONLY. IT IS NOT 508-COMPLIANT.\r\n PSC Graphics

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Specifications	THIS IS A VISUAL DESIGN FILE ONLY. IT IS NOT 508-COMPLIANT.\r\n PSC Graphics
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FORM FDA 2877 (1/11)PSC Publishing Services (301) 443-6740PREVIOUS EDITION IS OBSOLETE.PAGE 1 OF 2 PAGESEF D. DO NOT COMPLY W

Specifications	THIS IS A VISUAL DESIGN FILE ONLY. IT IS NOT 508-COMPLIANT.\r\n PSC Graphics
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Content	FORM FDA 2877 (1/11)PSC Publishing Services (301) 443-6740PREVIOUS EDITION IS OBSOLETE.PAGE 1 OF 2 PAGESEF D. DO NOT COMPLY WITH PERFORMANCE STANDARDS;ARE HELD AND WILL REMAIN UNDER BOND; AND WILL NOT BE INTRODUCED INTO COMMERCE UNTIL NOTIFICATION IS RECEIVED FROM FDA THAT PRODUCTS HAVE BEEN BROUGHT INTO COMPLIANCE IN ACCORDANCE WITH AN FDA APPROVED PETITION.(See Form FDA 766.) 1. Approved Petition is attached.2. Petition Request is attached.3. Request will be submitted within 60 days. DEPARTMENT OF HEALTH AND HUMAN SERVICES FOOD AND DRUG ADMINISTRATION Form Approved OMB No. 0910-0025 Expiration Date: October 31, 2013 DECLARATION FOR IMPORTED ELECTRONIC PRODUCTS SUBJECT TO RADIATION CONTROL STANDARDS INSTRUCTIONS U.S. CUSTOMS PORT OF ENTRY NAME & ADDRESS OF MANUFACTURING SITE; COUNTRY OF ORIGIN 1. If submitting entries electronically through ACS/ABI, hold FDA-2877 in entry file. Do not submit to FDA unless requested. 2. If submitting paper entry documents, submit the following to FDA: a. 2 copies of Customs Entry Form (e.g. CF 3461, CF 3461 Alt, CF 7501, etc.) b. 1 copy of FDA 2877 c. Commercial Invoice(s) in English. ENTRY NUMBER PRODUCT DESCRIPTION DATE OF ENTRY NAME AND TITLE OF RESPONSIBLE PERSON QUANTITY(Items/Containers) C. DO NOT COMPLY WITH PERFORMANCE STANDARDS;ARE BEING HELD UNDER A TEMPORARY IMPORT BOND; WILL NOT BE INTRODUCED INTO COMMERCE; WILL BE USED UNDER A RADIATION PROTECTION PLAN; AND WILL BE DESTROYED OR EXPORTED UNDER U.S. CUSTOMS SUPERVISION WHEN THE FOLLOWING MISSION IS COMPLETE: 1. Research, Investigations/Studies, or Training (attach Form FDA 766) 2. Trade Show/Demonstration; List dates & use restrictions . DECLARATION: I / WE DECLARE THAT THE PRODUCTS IDENTIFIED ABOVE:(Mark X applicable statements, fill in blanks, & sign) B. COMPLY WITH THE PERFORMANCE STANDARDSWHICH ARE APPLICABLE AT DATE OF MANUFACTURE AND THAT A CERTIFICATION LABEL OR TAG TO THIS EFFECT IS AFFIXED TO EACH PRODUCT. COMPLIANCE DOCUMENTED IN: 1. Last annual report or Product/Initial report 2. Unknown manufacturer or report number; State reason: NAME & ADDRESS OF IMPORTER & ULTIMATE CONSIGNEE(if not importer) ACCESSION NUMBER of Report Public reporting burden for this collection of informationis estimated to average 0.2 hour per response, including the time for reviewing instructions, searching existing data sources, gathering and maintaining the data needed, and completing and reviewing the collection of information. Send comments regarding this burden estimate or any other aspect of this collection of information, including suggestions for reducing this burden to: Name of MANUFACTURER OF RECORD(Filed report with FDA/CDRH) WARNING: Any person who knowingly makes a false declaration may be fined not more than $10,000 or imprisoned not more than 5 years or both, pursuant to Title 18 U.S.C. 1001. Any person importing a non-compliant electronic product may also be subject to civil penalties of $1000 per violation, up to a maximum $300,000 for related violations pursuant to Title 21 U.S.C. 360pp. Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer 1350 Piccard Drive, Room 400 Rockville, MD 20850 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. A. ARE NOT SUBJECT TO RADIATION PERFORMANCE STANDARDS BECAUSE THEY: 1. Were manufactured prior to the effective date of any applicable standard; Date of Manufacture . 2. Are excluded by the applicability clause or definition in the standard or by FDA written guidance. Specify reason for exclusion . 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). 4. Are property of a party residing outside the U.S. and will be returned to the owner after repair or servicing. 5. Are components or subassemblies to be used in manufacturing or as replacement parts (NOT APPLICABLE to diagnostic x-ray parts). 6. Are prototypes intended for on going product development by the importing firm, are labeled FOR TEST/EVALUATION ONLY, and will be exported, destroyed, or held for future testing (i.e., not distributed). (Quantities Limited - see reverse.) 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, or transferred without FDA approval. MODEL NUMBER(S) & BRAND NAME(S) SIGNATURE OF IMPORTER OF RECORD
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Following Datasheets	UCM080788_1 (4 pages) UCM080796_1 (2 pages) UCM080814_1 (2 pages) UCM080839_1 (3 pages) UCM080858_1 (3 pages) UCM080872_1 (1 pages) ucm080879-1_1 (2 pages) UCM081561_1 (84 pages) UCM081575_1 (32 pages) UCM081600 (76 pages)
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