The following data is part of a premarket notification filed by Triad Life Sciences, Inc. with the FDA for Innovaburn.
| Device ID | K213716 |
| 510k Number | K213716 |
| Device Name: | InnovaBurn |
| Classification | Wound Dressing With Animal-derived Material(s) |
| Applicant | Triad Life Sciences, Inc. 1770 Moriah Woods Blvd, Suite 18 Memphis, TN 38117 |
| Contact | Bill Willis |
| Correspondent | Donna Best Triad Life Sciences, Inc. 1770 Moriah Woods Blvd, Suite 18 Memphis, TN 38117 |
| 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 | 2021-11-24 |
| Decision Date | 2022-09-29 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00850002643473 | K213716 | 000 |
| 00850002643466 | K213716 | 000 |
| 00850002643459 | K213716 | 000 |
| 00850002643442 | K213716 | 000 |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() INNOVABURN 90337285 not registered Live/Pending |
Triad Life Sciences, Inc. 2020-11-23 |