FDA 510(k)

Hair Growth System

Número K: K190685 · 2019-07-26

RequerenteXuzhou Kernel Medical Equipment Co., Ltd.

Data da decisão2019-07-26

Código do produtoOAP

Comité consultivoPM

DecisãoSubstantially Equivalent

Resumo do dispositivo

Hair Growth System is the device name listed in this FDA 510(k) record. The listed applicant is Xuzhou Kernel Medical Equipment Co., Ltd.. It received FDA 510(k) clearance on 2019-07-26 under 510(k) number K190685. The device is classified under product code OAP. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Hair Growth System?

Hair Growth System is a medical device that received FDA 510(k) clearance on 2019-07-26. The listed applicant is Xuzhou Kernel Medical Equipment Co., Ltd.. The 510(k) number is K190685.

When did Hair Growth System receive FDA 510(k) clearance?

Hair Growth System received FDA 510(k) clearance on 2019-07-26, under 510(k) number K190685.

Who is the listed applicant for Hair Growth System?

The FDA 510(k) record lists Xuzhou Kernel Medical Equipment Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Hair Growth System?

The FDA product code for Hair Growth System is OAP.

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Dispositivos Relacionados (Código: OAP)

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