510(k) K080868
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 14, 2009
- Date Received
- March 28, 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