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510(k) K161034

Microcyn Plus Wound Care Solution by Oculus Innovative Sciences — Product Code FRO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 19, 2016
Date Received
April 13, 2016
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

Other clearances by Oculus Innovative Sciences

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  • K152055 — Ceramax Skin Barrier Cream (November 23, 2015)
  • K143590 — Alevicyn SG Antipruritic Gel (June 4, 2015)
  • K141352 — ENDOCYN ROOT CANAL IRRIGATION SOLUTION (August 18, 2014)
  • K141012 — HYDROCLEANSE WOUND CARE SOLUTION (August 8, 2014)
  • K131672 — MICROCYN SCAR MANAGEMENT HYDROGEL (November 15, 2013)
  • K102945 — PEDIACYN ATOPIC DERMATITIS HYDROGEL (February 2, 2011)
  • K093585 — MICROCYN SKIN AND WOUND HYDROGEL (March 8, 2010)

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