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510(k) K181315

Antimicrobial gauze sponge dressing, Antimicrobial super sponge dressing, Antimicrobial non-woven sponge dressing by Winner Medical Co., Ltd. — Product Code FRO

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: February 14, 2019
Date Received: May 18, 2018
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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