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510(k) K024298

ANTIMICROBIAL ALGINATE DRESSING by Advanced Medical Solutions, Ltd. — Product Code FRO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 30, 2003
Date Received
December 24, 2002
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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  • K180634 — Surgical Silver Post Operative Dressing (August 7, 2018)
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  • K163062 — PHMB Antimicrobial Foam Wound Dressing (July 25, 2017)
  • K032742 — SILVER FOAM WOUND DRESSING (August 16, 2004)
  • K041316 — ANTIMICROBIAL ALGINATE DRESSING (August 5, 2004)
  • K010245 — ACTIVHEAL SCAR MANAGEMENT DRESSING (April 25, 2001)

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