510(k) K231564
K231564 is an FDA 510(k) premarket notification submitted by Winner Medical Co., Ltd. for the device "Skin and Wound Cleanser". The FDA issued a decision of Substantially Equivalent on November 10, 2023. 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
- November 10, 2023
- Date Received
- May 31, 2023
- 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