510(k) K202982
K202982 is an FDA 510(k) premarket notification submitted by Winner Medical Co., Ltd. for the device "Silver Alginate Dressing (Prescription use), Antibacterial Alginate Would Dressing (OTC use)". The FDA issued a decision of Substantially Equivalent on October 19, 2021. The device falls under product code FRO (Dressing, Wound, Drug), a Class U device. Winner Medical Co., Ltd. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 19, 2021
- Date Received
- September 30, 2020
- Clearance Type
- Traditional
- 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