FDA 510(k)

SUNTOUCH Dental Dressing

Número K: K173196 · 2018-01-24

RequerenteHuizhou Foryou Medical Devices Co., Ltd.

Data da decisão2018-01-24

Código do produtoOLR

DecisãoSubstantially Equivalent

Resumo do dispositivo

SUNTOUCH Dental Dressing is the device name listed in this FDA 510(k) record. The listed applicant is Huizhou Foryou Medical Devices Co., Ltd.. It received FDA 510(k) clearance on 2018-01-24 under 510(k) number K173196. The device is classified under product code OLR. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the SUNTOUCH Dental Dressing?

SUNTOUCH Dental Dressing is a medical device that received FDA 510(k) clearance on 2018-01-24. The listed applicant is Huizhou Foryou Medical Devices Co., Ltd.. The 510(k) number is K173196.

When did SUNTOUCH Dental Dressing receive FDA 510(k) clearance?

SUNTOUCH Dental Dressing received FDA 510(k) clearance on 2018-01-24, under 510(k) number K173196.

Who is the listed applicant for SUNTOUCH Dental Dressing?

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

What is the FDA product code for SUNTOUCH Dental Dressing?

The FDA product code for SUNTOUCH Dental Dressing is OLR.

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Fonte oficial

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