510(k) K220673
K220673 is an FDA 510(k) premarket notification submitted by Qingdao Bright Moon Biomedical Materials Co., Ltd. for the device "Sterile Silver Alginate Wound Dressing". The FDA issued a decision of Substantially Equivalent on March 16, 2023. The device falls under product code FRO (Dressing, Wound, Drug), a Class U device. Qingdao Bright Moon Biomedical Materials Co., Ltd. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 16, 2023
- Date Received
- March 7, 2022
- 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