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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 K152055
Device Name Ceramax Skin Barrier Cream
Applicant
OCULUS INNOVATIVE SCIENCES
1129 N. MCDOWELL BOULEVARD
PETALUMA,  CA  94954
Applicant Contact BRIAN W. MARTIN
Correspondent
OCULUS INNOVATIVE SCIENCES
1129 N. MCDOWELL BOULEVARD
PETALUMA,  CA  94954
Correspondent Contact BRIAN W. MARTIN
Classification Product Code
FRO  
Date Received07/24/2015
Decision Date 11/23/2015
Decision Substantially Equivalent (SESE)
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product Yes
Recalls CDRH Recalls
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