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FDA 510(k)

Microcyn Antimicrobial Hydrogel

K-Number: K173896 · 2018-04-02

ApplicantSonoma Pharmaceuticals, Inc.
Decision Date2018-04-02
Product CodeFRO
DecisionSubstantially Equivalent

Device Summary

Microcyn Antimicrobial Hydrogel is a medical device manufactured by Sonoma Pharmaceuticals, Inc.. It received FDA 510(k) clearance on 2018-04-02 under approval number K173896. The device is classified under product code FRO. Product code FRO falls under the category of Anesthesiology, which includes devices for anesthetic delivery and patient monitoring. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Microcyn Antimicrobial Hydrogel?

Microcyn Antimicrobial Hydrogel is a medical device that received FDA 510(k) clearance on 2018-04-02. It is manufactured by Sonoma Pharmaceuticals, Inc.. The 510(k) number is K173896.

When was Microcyn Antimicrobial Hydrogel approved by the FDA?

Microcyn Antimicrobial Hydrogel received FDA 510(k) clearance on 2018-04-02, under approval number K173896.

What company makes Microcyn Antimicrobial Hydrogel?

Microcyn Antimicrobial Hydrogel is manufactured by Sonoma Pharmaceuticals, Inc..

What is the FDA product code for Microcyn Antimicrobial Hydrogel?

The FDA product code for Microcyn Antimicrobial Hydrogel is FRO. This falls under the Anesthesiology category.

Other Devices by Sonoma Pharmaceuticals, Inc.

K171935Alevicyn SG Antimicrobial Gel K172851Microcyn Plus Antimicrobial Wound Care Solution K240510Microdacyn Hydrogel K233399Microdacyn Wound Care Solution

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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