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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 K090206
Device Name OCULUS PURACYN ANTIMICROBIAL SKIN AND WOUND CLEANSER
Applicant
Oculus Innovative Sciences, Inc.
1135 N. Mc Dowell Blvd.
Petaluma,  CA  94954
Applicant Contact ANTOINETTE DOUGLAS
Correspondent
Oculus Innovative Sciences, Inc.
1135 N. Mc Dowell Blvd.
Petaluma,  CA  94954
Correspondent Contact ANTOINETTE DOUGLAS
Classification Product Code
FRO  
Date Received01/28/2009
Decision Date 06/02/2009
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
Recalls CDRH Recalls
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