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510(k) K073197

SILVER ANTIMICROBIAL WOUND GEL by Advanced Medical Solutions Limited — Product Code FRO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 28, 2008
Date Received
November 13, 2007
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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  • K070581 — SILVER ALGINATE II WOUND DRESSING (July 13, 2007)
  • K063173 — MODIFICATION TO SILVER ALGINATE II WOUND DRESSING (November 3, 2006)

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