FDA 510(k)

Sterile Disposable Syringes

Número K: K172694 · 2018-07-06

RequerenteShenyang Mastech Medical Device Co., Ltd.

Data da decisão2018-07-06

Código do produtoDXT

Comité consultivoCV

DecisãoSubstantially Equivalent

Resumo do dispositivo

Sterile Disposable Syringes is the device name listed in this FDA 510(k) record. The listed applicant is Shenyang Mastech Medical Device Co., Ltd.. It received FDA 510(k) clearance on 2018-07-06 under 510(k) number K172694. The device is classified under product code DXT. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Sterile Disposable Syringes?

Sterile Disposable Syringes is a medical device that received FDA 510(k) clearance on 2018-07-06. The listed applicant is Shenyang Mastech Medical Device Co., Ltd.. The 510(k) number is K172694.

When did Sterile Disposable Syringes receive FDA 510(k) clearance?

Sterile Disposable Syringes received FDA 510(k) clearance on 2018-07-06, under 510(k) number K172694.

Who is the listed applicant for Sterile Disposable Syringes?

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

What is the FDA product code for Sterile Disposable Syringes?

The FDA product code for Sterile Disposable Syringes is DXT.

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Dispositivos Relacionados (Código: DXT)

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Fonte oficial

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