510(k) K962851
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 6, 1996
- Date Received
- July 22, 1996
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Dressing, Wound And Burn, Hydrogel W/Drug And/Or Biologic
- Device Class
- Class U
- Regulation Number
- Review Panel
- SU
- Submission Type