FDA 510(k)

Disposable High Pressure Syringe

Numéro K : K170279 · 2017-12-12

DemandeurUnion Medical Shenzhen Co., Ltd.

Date de décision2017-12-12

Code produitDXT

Comité consultatifCV

DécisionSubstantially Equivalent

Résumé du dispositif

Disposable High Pressure Syringe is the device name listed in this FDA 510(k) record. The listed applicant is Union Medical Shenzhen Co., Ltd.. It received FDA 510(k) clearance on 2017-12-12 under 510(k) number K170279. The device is classified under product code DXT. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Questions fréquentes

What is the Disposable High Pressure Syringe?

Disposable High Pressure Syringe is a medical device that received FDA 510(k) clearance on 2017-12-12. The listed applicant is Union Medical Shenzhen Co., Ltd.. The 510(k) number is K170279.

When did Disposable High Pressure Syringe receive FDA 510(k) clearance?

Disposable High Pressure Syringe received FDA 510(k) clearance on 2017-12-12, under 510(k) number K170279.

Who is the listed applicant for Disposable High Pressure Syringe?

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

What is the FDA product code for Disposable High Pressure Syringe?

The FDA product code for Disposable High Pressure Syringe is DXT.

Essais cliniques associés

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Dispositifs connexes (Code : DXT)

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Source officielle

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