510(k) K113866
K113866 is an FDA 510(k) premarket notification submitted by Brennen Medical, LLC for the device "PORCINE DERMAL XENOGRAFTS PORCINE DERMAL MATRIX". The FDA issued a decision of Substantially Equivalent on March 23, 2012. The device falls under product code KGN (Wound Dressing With Animal-Derived Material(S)), a Class U device. Brennen Medical, LLC has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 23, 2012
- Date Received
- December 30, 2011
- 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