FDA-3541.p65 PSC Graphics

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Specifications	FDA-3541.p65 PSC Graphics
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Reviewing Branch:. Please be advised that the average total time (time for FDA review plus time spent awaiting any additional

Specifications	FDA-3541.p65 PSC Graphics
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Content	Reviewing Branch:. Please be advised that the average total time (time for FDA review plus time spent awaiting any additional data) for review of a device assigned to this branch has been days over the last 6 months. FORM FDA 3541 (12/10)EFPSC Graphics (301) 443-6740 Single Form – To be used for both your request and FDA’s response. Requesters should fill in the information on the top half of this form (Request Section) and fax (or mail) this form to the FDA at the fax # or address listed below. The FDA will complete the information on the bottom half (Response Section) and return by fax (or mail). PREMARKET NOTIFICATION [510(K)] STATUS REQUEST AND RESPONSE Department of Health and Human Services Food and Drug Administration Center for Devices and Radiological Health REQUEST SECTION(To be completed by requester) To (From) FDA, Center for Devices & Radiological Health Division of Small Manufacturers, International and Consumer Assistance (DSMICA) Attn: 510(k) Status Coordinator 10903 New Hampshire Avenue WO66-4613 Silver Spring, MD 20993 USA Fax Number: (301) 847-8149 Phone: (301) 796-7100 or (800) 638-2041 Requester Certification: I certify that I am an authorized representative of the submitter of the following 510(k) and that all information provided herein is truthful to the best of my knowledge. Please provide me with informa- tion related to the status of the following 510(k) submission via (mark one):FAXor MAIL RESPONSE SECTION(To be completed by FDA) NOTE: THIS DOCUMENT IS INTENDED ONLY FOR THE USE OF THE PARTY TO WHOM IT IS ADDRESSED AND CONTAINS INFORMATION THAT IS PRIVILEGED, CONFIDENTIAL, AND PROTECTED FROM DIS- CLOSURE UNDER APPLICABLE LAW. If you are not the addressee, or authorized to deliver this document to the addressee, you are hereby notified that review, disclosure, dissemination, copying, or other action based on the content of this communication is not authorized. If document has been received in error, please notify FDA by phone and return via mail. Place in Queue: Your 510(k) has been assigned to a reviewer and is # in line for that reviewer to work on. The length of time that it will take for the reviewer to get to your 510(k) and to review it will depend on many factors, such as the complexity of the 510(k)’s that are in line ahead of you, and other work assigned to the reviewer, for example the review of investigational device exemption submissions. Because of these variables, we cannot estimate a completion date for review of your 510(k). However, future inquiries can give you an idea of how your 510(k) is progressing. LAST ACTION AND DATE From (To) REQUESTER NAME MAILING ADDRESS FAX NUMBER TELEPHONE NUMBER REQUESTER’S AFFILIATION WITH THE SUBMITTER OF THE 510(K) 510(K) NUMBER SPONSOR’S NAME AND ADDRESS REQUESTER SIGNATURE PRODUCT NAME DATE LOGGED IN BY FDA (ODE) – as identified in acknowledgement letter FDA RESPONSE DATE Please do not request another status report prior to 30 days from the FDA response date. Page 1 Form Approved: OMB No. 0910-0120; Expiration Date: 12/31/2013
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Following Datasheets	UCM081561_1 (84 pages) UCM081575_1 (32 pages) UCM081600 (76 pages) UCM081603_1 (17 pages) UCM081667_1 (2 pages) UCM081671 (76 pages) UCM082348_1 (4 pages) UCM082359_1 (2 pages) UCM082725-1_1 (1 pages) UCM082725_1 (1 pages)
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