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 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00850002643503 | K210580 | 000 |
| 00850002643497 | K210580 | 000 |
| 00850002643480 | K210580 | 000 |