FDA 510(k)

Microcyn Plus Antimicrobial Wound Care Solution

Número K: K172851 · 2017-11-15

Data da decisão2017-11-15

Código do produtoFRO

DecisãoSubstantially Equivalent

Resumo do dispositivo

Microcyn Plus Antimicrobial Wound Care Solution 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 2017-11-15 under 510(k) number K172851. 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.

Perguntas frequentes

What is the Microcyn Plus Antimicrobial Wound Care Solution?

Microcyn Plus Antimicrobial Wound Care Solution is a medical device that received FDA 510(k) clearance on 2017-11-15. The listed applicant is Sonoma Pharmaceuticals, Inc.. The 510(k) number is K172851.

When did Microcyn Plus Antimicrobial Wound Care Solution receive FDA 510(k) clearance?

Microcyn Plus Antimicrobial Wound Care Solution received FDA 510(k) clearance on 2017-11-15, under 510(k) number K172851.

Who is the listed applicant for Microcyn Plus Antimicrobial Wound Care Solution?

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 Microcyn Plus Antimicrobial Wound Care Solution?

The FDA product code for Microcyn Plus Antimicrobial Wound Care Solution is FRO. This falls under the Anesthesiology category.

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Outros registros que listam Sonoma Pharmaceuticals, Inc. como candidato(a)

K261023Microdacyn Wound Irrigation Solution K240510Microdacyn Hydrogel K233399Microdacyn Wound Care Solution K173896Microcyn Antimicrobial Hydrogel K171935Alevicyn SG Gel Antimicrobiano

Dispositivos Relacionados (Código: FRO)

K254168Actolind® (06.3637. Actolind® Gel Plus)ACTO GmbH K254041SkinSmart Antimicrobial HydroGelMagic Science Supply, LLC K261646Redermax® Antibacterial Wound MatrixBeijing Kreate Medical Co., Ltd.K253665Vashe Plus Antimicrobial SolutionUrgo Medical North America, LLC K251929SilverCeuticals® Antimicrobial Wound GelSilverceuticals, Inc.K261023Microdacyn Wound Irrigation SolutionSonoma Pharmaceuticals, Inc.

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