APPENDIX N - PREMARKET NOTIFICATION [510(K)] STATUS REQUEST & RESPONSE

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).

To (From)	From (To)
510(k) Status Coordinator	Requester Name:______________________
Div. of Small Manufacturers Assist.	Mailing Address:______________________
FDA, Center for Devices &	___________________________________
Radiological Health	___________________________________
5600 Fishers Lane (HFZ-220)	FAX Number:________________________
Rockville, MD 20857 USA	Telephone Number: ___________________
Fax Number: 240-276-3151	Requester's Affiliation with
Phone: 240-276-3150 or 800-638-2041	the submitter of the 510(k): _____________

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 information related to the status of the following 510(k) submission via : FAX [ ] or MAIL [ ]

510(K) Number: K____________ Requester Signature: ____________________________
Sponsor's Name and Address: ____________________________________________________
Product Name: ______________________________________________

Date logged in by FDA (ODE) as identified in acknowledgement letter: ___________

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 DISCLOSURE 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.

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.

Last Action and Date:______________

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. Due to 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.

FDA Response Date: ______________ Please do not request another status report prior to 30 days from the FDA response date.

Public Reporting burden for this collection of information is 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 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:

Food and Drug Administration
CDRH (HFZ-220)
2094 Gaither Road
Rockville, MD 20850