510(k) K140820
K140820 is an FDA 510(k) premarket notification submitted by Viscus Biologics, LLC for the device "XENOMEM WOUND MATRIX". The FDA issued a decision of Substantially Equivalent on Jun 26, 2015. The device falls under product code KGN (Wound Dressing With Animal-Derived Material(S)), a Class U device. Viscus Biologics, LLC has 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Jun 26, 2015
- Date Received
- Apr 1, 2014
- 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)