The following data is part of a premarket notification filed by Triad Life Sciences, Inc. with the FDA for Innovamatrix Pd.
Device ID | K211902 |
510k Number | K211902 |
Device Name: | InnovaMatrix PD |
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 | 2021-06-21 |
Decision Date | 2022-09-28 |