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 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
INNOVABURN 90337285 not registered Live/Pending |
Triad Life Sciences, Inc. 2020-11-23 |