FDA 510(k)

Microcyn 抗菌皮肤和伤口清洁剂

K号: K172622 · 2017-11-21

决定日期2017-11-21

产品代码FRO

决定实质等同

器械摘要

Microcyn Antimicrobial Skin and Wound Cleanser is the device name listed in this FDA 510(k) record. The listed applicant is Sonoma Pharmaceuticals. It received FDA 510(k) clearance on 2017-11-21 under 510(k) number K172622. 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 Microcyn Antimicrobial Skin and Wound Cleanser?

Microcyn Antimicrobial Skin and Wound Cleanser is a medical device that received FDA 510(k) clearance on 2017-11-21. The listed applicant is Sonoma Pharmaceuticals. The 510(k) number is K172622.

When did Microcyn Antimicrobial Skin and Wound Cleanser receive FDA 510(k) clearance?

Microcyn Antimicrobial Skin and Wound Cleanser received FDA 510(k) clearance on 2017-11-21, under 510(k) number K172622.

Who is the listed applicant for Microcyn Antimicrobial Skin and Wound Cleanser?

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

What is the FDA product code for Microcyn Antimicrobial Skin and Wound Cleanser?

The FDA product code for Microcyn Antimicrobial Skin and Wound Cleanser is FRO. This falls under the Anesthesiology category.

列明Sonoma Pharmaceuticals为申报人的其他记录

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