510(k) K221754
Ag Foam Dressing Non-Adhesive (OTC); Ag Foam Dressing Adhesive (OTC); Silicone Ag Foam Dressing (OTC); Silicone Ag Foam Dressing with Border (OTC) by
Winner Medical Co., Ltd.
— Product Code FRO
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 17, 2023
- Date Received
- June 16, 2022
- Clearance Type
- Special
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Dressing, Wound, Drug
- Device Class
- Class U
- Regulation Number
- Review Panel
- SU
- Submission Type