510(k) K981713
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 31, 1998
- Date Received
- May 15, 1998
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Dressing, Wound And Burn, Occlusive
- Device Class
- Class U
- Regulation Number
- Review Panel
- SU
- Submission Type