510(k) K193552
K193552 is an FDA 510(k) premarket notification submitted by Triad Life Sciences, Inc. for the device "InnovaMatrix". The FDA issued a decision of Substantially Equivalent on Oct 21, 2020. 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
- Oct 21, 2020
- Date Received
- Dec 20, 2019
- Clearance Type
- Traditional
- 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)