510(k) K874161
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 4, 1987
- Date Received
- October 13, 1987
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Dressing, Wound, Occlusive
- Device Class
- Class I
- Regulation Number
- 878.4020
- Review Panel
- SU
- Submission Type