FDA 510(k)

Alevicyn SG 抗菌凝胶

K号: K171935 · 2017-12-01

决定日期2017-12-01

产品代码FRO

决定实质等同

器械摘要

Alevicyn SG Antimicrobial Gel is the device name listed in this FDA 510(k) record. The listed applicant is Sonoma Pharmaceuticals, Inc.. It received FDA 510(k) clearance on 2017-12-01 under 510(k) 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.

常见问题

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. The listed applicant is Sonoma Pharmaceuticals, Inc.. The 510(k) number is K171935.

When did Alevicyn SG Antimicrobial Gel receive FDA 510(k) clearance?

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

Who is the listed applicant for Alevicyn SG Antimicrobial Gel?

The FDA 510(k) record lists Sonoma Pharmaceuticals, Inc. as the applicant. This does not by itself establish the device manufacturer.

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.

列明Sonoma Pharmaceuticals, Inc.为申报人的其他记录

关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。

K261023Microdacyn 伤口冲洗溶液 K240510Microdacyn 水凝胶 K233399Microdacyn 伤口护理溶液 K173896Microcyn 抗菌水凝胶 K172851Microcyn Plus 抗菌伤口护理溶液

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