Home / 510(k) Clearances / K192463

510(k) K192463

PHMB Foam Dressing Non-Adhesive, PHMB Foam Dressing Adhesive, Silicone PHMB Foam Dressing, Silicone PHMB 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
September 9, 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

Other clearances by Winner Medical Co., Ltd.

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  • K231564 — Skin and Wound Cleanser (November 10, 2023)
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  • K221311 — Antibacterial Bandage (June 21, 2023)
  • K223232 — Procedure mask/Surgical mask/Face mask (March 6, 2023)
  • K221532 — PHMB Wound Dressing (January 30, 2023)
  • K221754 — Ag Foam Dressing Non-Adhesive (OTC); Ag Foam Dressing Adhesive (OTC); Silicone A (January 17, 2023)
  • K221755 — Antimicrobial gauze sponge dressing; Antimicrobial super sponge dressing; Antimi (January 13, 2023)

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