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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 K233399
Device Name Microdacyn Wound Care Solution
Applicant
Sonoma Pharmaceuticals, Inc.
1129 N. Mcdowell Blvd.
Petaluma,  CA  94954
Applicant Contact Everardo Garibay Ramirez
Correspondent
Sonoma Pharmaceuticals, Inc.
1129 N. Mcdowell Blvd.
Petaluma,  CA  94954
Correspondent Contact Everardo Garibay Ramirez
Classification Product Code
FRO  
Date Received10/04/2023
Decision Date 09/13/2024
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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