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510(k) K131672

MICROCYN SCAR MANAGEMENT HYDROGEL by Oculus Innovative Sciences — Product Code PFP

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 15, 2013
Date Received
June 6, 2013
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Silicone Hydrogel For Scar Management
Device Class
Class I
Regulation Number
878.4025
Review Panel
SU
Submission Type

Management of closed hyperproliferative (hypertrophic and keloid) scars.

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