[Code of Federal Regulations]
[Title 21, Volume 8]
[Revised as of April 1, 2002]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR807.90]

[Page 70]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                          SERVICES (CONTINUED)
 
PART 807--ESTABLISHMENT REGISTRATION AND DEVICE LISTING FOR MANUFACTURERS AND INITIAL IMPORTERS OF DEVICES--Table of Contents
 
              Subpart E--Premarket Notification Procedures
 
Sec. 807.90  Format of a premarket notification submission.

    Each premarket notification submission pursuant to this part shall 
be submitted in accordance with this section. Each submission shall:
    (a)(1) For devices regulated by the Center for Devices and 
Radiological Health, be addressed to the Food and Drug Administration, 
Center for Devices and Radiological Health (HFZ-401), 9200 Corporate 
Blvd., Rockville, MD 20850.
    (2) For devices regulated by the Center for Biologics Evaluation and 
Research, be addressed to the Food and Drug Administration, Center for 
Biologics Evaluation and Research, Document Control Room (HFM-99), 1401 
Rockville Pike, Rockville, MD 20852-1448. Information about devices 
regulated by the Center for Biologics Evaluation and Research is 
available at http://www.fda.gov/cber/dap/devlst.htm on the Internet.
    (3) All inquiries regarding a premarket notification submission 
should be in writing and sent to one of the addresses above.
    (b) Be bound into a volume or volumes, where necessary.
    (c) Be submitted in duplicate on standard size paper, including the 
original and two copies of the cover letter.
    (d) Be submitted separately for each product the manufacturer 
intends to market.
    (e) Designated ``510(k) Notification'' in the cover letter.

[42 FR 42526, Aug. 23, 1977, as amended at 53 FR 11252, Apr. 6, 1988; 55 
FR 11169, Mar. 27, 1990; 65 FR 17137, Mar. 31, 2000]