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510(k) K252167

Enhanced Silver Gelling Fiber Dressing (OTC) Extra Enhanced Silver Gelling Fiber Dressing (Prescription) by Qingdao Bright Moon Biomedical Materials Co., Ltd. — Product Code FRO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 19, 2025
Date Received
July 10, 2025
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

Other clearances by Qingdao Bright Moon Biomedical Materials Co., Ltd.

  • K220673 — Sterile Silver Alginate Wound Dressing (March 16, 2023)

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