The following data is part of a premarket notification filed by Triad Life Sciences, Inc. with the FDA for Innovamatrix.
| Device ID | K193552 |
| 510k Number | K193552 |
| Device Name: | InnovaMatrix |
| Classification | Dressing, Wound, Collagen |
| Applicant | Triad Life Sciences, Inc. 1770 Moriah Woods Blvd, Suite 18 Memphis, TN 38117 |
| Contact | Russell I Olsen |
| 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 | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-12-20 |
| Decision Date | 2020-10-21 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00850002643183 | K193552 | 000 |
| 00850002643176 | K193552 | 000 |
| 00850002643169 | K193552 | 000 |
| 00850002643152 | K193552 | 000 |
| 00850002643145 | K193552 | 000 |
| 00850002643435 | K193552 | 000 |
| 00850002643428 | K193552 | 000 |
| 00850002643411 | K193552 | 000 |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() INNOVAMATRIX 88140058 not registered Live/Pending |
Triad Life Sciences, Inc. 2018-10-02 |