Microcyn Plus Antimicrobial Wound Care Solution

Dressing, Wound, Drug

Sonoma Pharmaceuticals, Inc.

The following data is part of a premarket notification filed by Sonoma Pharmaceuticals, Inc. with the FDA for Microcyn Plus Antimicrobial Wound Care Solution.

Pre-market Notification Details

Device IDK172851
510k NumberK172851
Device Name:Microcyn Plus Antimicrobial Wound Care Solution
ClassificationDressing, Wound, Drug
Applicant Sonoma Pharmaceuticals, Inc. 1129 N. McDowell Boulevard Petaluma,  CA  94954
ContactBrian Martin
CorrespondentBrian Martin
Sonoma Pharmaceuticals, Inc. 1129 N. McDowell Boulevard Petaluma,  CA  94954
Product CodeFRO  
CFR Regulation Number510(k) Premarket Notification [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductYes
Date Received2017-09-20
Decision Date2017-11-15
Summary:summary

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