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FDA 510(k)

Alevicyn SG Antimicrobial Gel

K-Number: K171935 · 2017-12-01

ApplicantSonoma Pharmaceuticals, Inc.
Decision Date2017-12-01
Product CodeFRO
DecisionSubstantially Equivalent

Device Summary

Alevicyn SG Antimicrobial Gel is a medical device manufactured by Sonoma Pharmaceuticals, Inc.. It received FDA 510(k) clearance on 2017-12-01 under approval number K171935. 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 Alevicyn SG Antimicrobial Gel?

Alevicyn SG Antimicrobial Gel is a medical device that received FDA 510(k) clearance on 2017-12-01. It is manufactured by Sonoma Pharmaceuticals, Inc.. The 510(k) number is K171935.

When was Alevicyn SG Antimicrobial Gel approved by the FDA?

Alevicyn SG Antimicrobial Gel received FDA 510(k) clearance on 2017-12-01, under approval number K171935.

What company makes Alevicyn SG Antimicrobial Gel?

Alevicyn SG Antimicrobial Gel is manufactured by Sonoma Pharmaceuticals, Inc..

What is the FDA product code for Alevicyn SG Antimicrobial Gel?

The FDA product code for Alevicyn SG Antimicrobial Gel is FRO. This falls under the Anesthesiology category.

Other Devices by Sonoma Pharmaceuticals, Inc.

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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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