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510(k) K041316

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

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 5, 2004
Date Received
May 17, 2004
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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  • K032742 — SILVER FOAM WOUND DRESSING (August 16, 2004)
  • K024298 — ANTIMICROBIAL ALGINATE DRESSING (June 30, 2003)
  • K010245 — ACTIVHEAL SCAR MANAGEMENT DRESSING (April 25, 2001)

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