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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 K173896
Device Name Microcyn Antimicrobial Hydrogel
Applicant
Sonoma Pharmaceuticals, Inc.
1129 N. Mcdowell Blvd.
Petaluma,  CA  94954
Applicant Contact Brian Martin
Correspondent
Sonoma Pharmaceuticals, Inc.
1129 N. Mcdowell Blvd.
Petaluma,  CA  94954
Correspondent Contact Brian Martin
Classification Product Code
FRO  
Date Received12/22/2017
Decision Date 04/02/2018
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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