510(k) K972081
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 17, 1997
- Date Received
- June 3, 1997
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Bandage, Liquid, Skin Protectant
- Device Class
- Class I
- Regulation Number
- 880.5090
- Review Panel
- SU
- Submission Type