510(k) K210580
K210580 is an FDA 510(k) premarket notification submitted by Triad Life Sciences, Inc. for the device "InnovaMatrix FS". The FDA issued a decision of Substantially Equivalent on Apr 21, 2021. The device falls under product code KGN (Wound Dressing With Animal-Derived Material(S)), a Class U device. Triad Life Sciences, Inc. has 3 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Apr 21, 2021
- Date Received
- Feb 26, 2021
- Clearance Type
- Special
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Wound Dressing With Animal-Derived Material(S)
- Device Class
- Class U
- Review Panel
- SU
- Submission Type
- 510(k)