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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Dressing, Wound, Drug
510(k) Number K090725
Device Name OCULUS MICROCYN WOUND GEL
Applicant
Oculus Innovative Sciences, Inc.
1135 N. Mc Dowell Blvd.
Petaluma,  CA  94954
Applicant Contact ANTIOINETTE DOUGLAS
Correspondent
Oculus Innovative Sciences, Inc.
1135 N. Mc Dowell Blvd.
Petaluma,  CA  94954
Correspondent Contact ANTIOINETTE DOUGLAS
Classification Product Code
FRO  
Date Received03/19/2009
Decision Date 05/20/2009
Decision Substantially Equivalent (SESE)
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product Yes
Predetermined Change
Control Plan Authorized		 No
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