The following data is part of a premarket notification filed by Triad Life Sciences, Inc. with the FDA for Innovamatrix Fs.
Device ID | K210580 |
510k Number | K210580 |
Device Name: | InnovaMatrix FS |
Classification | Dressing, Wound, Collagen |
Applicant | Triad Life Sciences, Inc. 1770 Moriah Woods Blvd, Suite 18 Memphis, TN 38117 |
Contact | Jon G. Hargis |
Correspondent | Stephen P. Rhodes Streamline Regulatory 3502 Dundee Driveway Chevy Chase, MD 20815 |
Product Code | KGN |
CFR Regulation Number | 510(k) Premarket Notification [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2021-02-26 |
Decision Date | 2021-04-21 |