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510(k) K110458

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

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 14, 2011
Date Received
February 17, 2011
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

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