Keyword Analysis & Research: 510k mask


Keyword Analysis


Keyword Research: People who searched 510k mask also searched

Frequently Asked Questions

Is there a draft guidance for premarket notification [510 (k) ] submissions for surgical mask?

This guidance supersedes “Draft Guidance for Industry and FDA Reviewers on the Content and Format of Premarket Notification [510 (k)] Submissions for Surgical Mask” issued January 16, 1998. For questions regarding this draft document, please contact Chiu S. Lin, Ph.D. at 301-796-5580.

What are the 510 (k) clearances?

510 (k) Clearances 1 Overview. Section 510 (k) of the Food, Drug and Cosmetic Act requires device manufacturers who must register, to notify FDA of their intent to market a medical device at least ... 2 General Information. ... 3 Federal Register Notices 4 Older Clearances

What is an abbreviated 510 (k)?

FDA believes an Abbreviated 510 (k) provides the least burdensome means of demonstrating substantial equivalence for a new device, particularly once FDA has issued a guidance document addressing that device. Manufacturers considering modifications to their own cleared devices may lessen the regulatory burden by submitting a Special 510 (k).

When did the FDA release the 510 (k) guidelines?

Document issued on: March 5, 2004 and a correction posted on July 14, 2004. This guidance supersedes “Draft Guidance for Industry and FDA Reviewers on the Content and Format of Premarket Notification [510 (k)] Submissions for Surgical Mask” issued January 16, 1998.


Search Results related to 510k mask on Search Engine