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510(k) K223310

Antimicrobial Silicone PHMB Foam Wound Dressing by Advanced Medical Solutions Limited — Product Code FRO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 5, 2023
Date Received
October 28, 2022
Clearance Type
Special
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 Advanced Medical Solutions Limited

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  • K091013 — SILVER PU ANTIBACTERIAL FOAM DRESSING - NON ADHERENT AND ISLAND (July 30, 2009)
  • K090453 — SILVER ALGINATE 11 WOUND DRESSING (February 26, 2009)
  • K080503 — SILVER ALGINATE IV ANTIMICROBIAL WOUND DRESSING (November 12, 2008)
  • K081363 — NON-ADHERENT ANTIMICROBIAL ALGINATE DRESSING, SILVERCEL NON-ADHERENT ANTIMICROBI (September 24, 2008)
  • K073197 — SILVER ANTIMICROBIAL WOUND GEL (August 28, 2008)
  • K070581 — SILVER ALGINATE II WOUND DRESSING (July 13, 2007)
  • K063173 — MODIFICATION TO SILVER ALGINATE II WOUND DRESSING (November 3, 2006)

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