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510(k) K141012

HYDROCLEANSE WOUND CARE SOLUTION by Oculus Innovative Sciences — Product Code FRO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 8, 2014
Date Received
April 21, 2014
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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  • K102945 — PEDIACYN ATOPIC DERMATITIS HYDROGEL (February 2, 2011)
  • K093585 — MICROCYN SKIN AND WOUND HYDROGEL (March 8, 2010)

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