510(k) K113836
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 24, 2012
- Date Received
- December 28, 2011
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Dressing, Wound, Drug
- Device Class
- Class U
- Regulation Number
- Review Panel
- SU
- Submission Type