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510(k) K153723

ACTICOAT Surgical Dressing by Smith & Nephew Medical Limited — Product Code FRO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 14, 2016
Date Received
December 28, 2015
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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