510(k) K210128
K210128 is an FDA 510(k) premarket notification submitted by Integra LifeSciences Corporation for the device "INTEGRA Wound Matrix (Macro-Channels)". The FDA issued a decision of Substantially Equivalent on October 8, 2021. The device falls under product code KGN (Wound Dressing With Animal-Derived Material(S)), a Class U device. Integra LifeSciences Corporation has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 8, 2021
- Date Received
- January 19, 2021
- 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
- Regulation Number
- Review Panel
- SU
- Submission Type