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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 K162217
Device Name LOYON
Applicant
Oculus Innovative Sciences
1129 N. Mcdowell Blvd.
Petaluma,  CA  94954
Applicant Contact Brian W. Martin
Correspondent
Oculus Innovative Sciences
1129 N. Mcdowell Blvd.
Petaluma,  CA  94954
Correspondent Contact Brian W. Martin
Classification Product Code
FRO  
Date Received08/08/2016
Decision Date 03/23/2017
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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