510(k) K231088
K231088 is an FDA 510(k) premarket notification submitted by Roosin Medical Co., Ltd. for the device "Copper Foam Dressing (Prescription and OTC)". The FDA issued a decision of Substantially Equivalent on January 11, 2024. The device falls under product code FRO (Dressing, Wound, Drug), a Class U device. Roosin Medical Co., Ltd. has at least 4 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 11, 2024
- Date Received
- April 17, 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