510(k) K081635
K081635 is an FDA 510(k) premarket notification submitted by Integra Lifesciences Corp. for the device "INTEGRA MESHED BILAYER WOUND MATRIX". The FDA issued a decision of Substantially Equivalent on December 4, 2008. The device falls under product code KGN (Wound Dressing With Animal-Derived Material(S)), a Class U device. Integra Lifesciences Corp. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 4, 2008
- Date Received
- June 11, 2008
- 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