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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 K041161
Device Name MICROCYN WOUND CARE DRESSING
Applicant
OCULUS INNOVATIVE SCIENCES, INC.
1129 N. MCDOWELL BLVD.
PETALUMA,  CA  94954
Applicant Contact MANISHA S DESHMUKH
Correspondent
OCULUS INNOVATIVE SCIENCES, INC.
1129 N. MCDOWELL BLVD.
PETALUMA,  CA  94954
Correspondent Contact MANISHA S DESHMUKH
Classification Product Code
FRO  
Date Received05/03/2004
Decision Date 05/03/2005
Decision Substantially Equivalent (SESE)
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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