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510(k) K152055

Ceramax Skin Barrier Cream by Oculus Innovative Sciences — Product Code FRO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 23, 2015
Date Received
July 24, 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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  • K093585 — MICROCYN SKIN AND WOUND HYDROGEL (March 8, 2010)

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