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Frequently Asked Questions

How do I submit a 510k to the FDA?

A 510 (k) submission must be submitted in an electronic format (eCopy). Once a 510 (k) submission is received by the FDA, we do NOT return the submission or any copies to the submitter. You should retain a copy of your 510 (k) for your records.

What are the requirements for a traditional 510 (k) submission?

A Traditional 510(k) submission must include the required elements identified in 21 CFR 807.87 (Information required in a premarket notification submission). CDRH recommends that you follow the Traditional 510(k) format provided in the guidance document, "Format for Traditional and Abbreviated 510(k)s.".

Where can I find the DCC’s mailing address for a 510 (k)?

The current mailing address for CDRH’s DCC and a link to CBER’s DCC’s mailing address are provided on the eCopy Program for Medical Device Submissions webpage. When the DCC receives the 510 (k) submission, it assigns the submission a unique control number.

What is a 510 (k) control number?

When the DCC receives the 510 (k) submission, it assigns the submission a unique control number. This number is commonly referred to as the " 510 (k) number ," or " K number. " The 510 (k) number begins with the letter "K" followed by 6 digits.


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