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510(k) K191819

Ag Foam Dressing Non-Adhesive, Ag Foam Dressing Adhesive, Silicone Ag Foam Dressing, Silicone Ag Foam Dressing with Border by Winner Medical Co., Ltd. — Product Code FRO

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: May 14, 2020
Date Received: July 5, 2019
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

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