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510(k) K183645

Silver High Performance Dressing by Advanced Medical Solutions, Ltd. — Product Code FRO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 29, 2019
Date Received
December 26, 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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  • K181197 — PHMB Foam Wound Dressing (August 3, 2018)
  • K163062 — PHMB Antimicrobial Foam Wound Dressing (July 25, 2017)
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  • K041316 — ANTIMICROBIAL ALGINATE DRESSING (August 5, 2004)
  • K024298 — ANTIMICROBIAL ALGINATE DRESSING (June 30, 2003)
  • K010245 — ACTIVHEAL SCAR MANAGEMENT DRESSING (April 25, 2001)

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