510(k) K942798
Clearance Details
- Decision
- SN ()
- Decision Date
- July 11, 1994
- Date Received
- June 15, 1994
- 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