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FDA 510(k)

Sterile Hypodermic Syringe for Single use, with/without needle, Sterile Insulin Syringe for Single use, with needle, Sterile Hypodermic needle for Single use

Número K: K190002 · 2019-09-12

RequerenteShanghai Kohope Medical Devices Co., Ltd.
Data da decisão2019-09-12
Código do produtoFMF
Comité consultivoHO
DecisãoSubstantially Equivalent

Resumo do dispositivo

Sterile Hypodermic Syringe for Single use, with/without needle, Sterile Insulin Syringe for Single use, with needle, Sterile Hypodermic needle for Single use is the device name listed in this FDA 510(k) record. The listed applicant is Shanghai Kohope Medical Devices Co., Ltd.. It received FDA 510(k) clearance on 2019-09-12 under 510(k) number K190002. The device is classified under product code FMF. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Sterile Hypodermic Syringe for Single use, with/without needle, Sterile Insulin Syringe for Single use, with needle, Sterile Hypodermic needle for Single use?

Sterile Hypodermic Syringe for Single use, with/without needle, Sterile Insulin Syringe for Single use, with needle, Sterile Hypodermic needle for Single use is a medical device that received FDA 510(k) clearance on 2019-09-12. The listed applicant is Shanghai Kohope Medical Devices Co., Ltd.. The 510(k) number is K190002.

When did Sterile Hypodermic Syringe for Single use, with/without needle, Sterile Insulin Syringe for Single use, with needle, Sterile Hypodermic needle for Single use receive FDA 510(k) clearance?

Sterile Hypodermic Syringe for Single use, with/without needle, Sterile Insulin Syringe for Single use, with needle, Sterile Hypodermic needle for Single use received FDA 510(k) clearance on 2019-09-12, under 510(k) number K190002.

Who is the listed applicant for Sterile Hypodermic Syringe for Single use, with/without needle, Sterile Insulin Syringe for Single use, with needle, Sterile Hypodermic needle for Single use?

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

What is the FDA product code for Sterile Hypodermic Syringe for Single use, with/without needle, Sterile Insulin Syringe for Single use, with needle, Sterile Hypodermic needle for Single use?

The FDA product code for Sterile Hypodermic Syringe for Single use, with/without needle, Sterile Insulin Syringe for Single use, with needle, Sterile Hypodermic needle for Single use is FMF.

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Dispositivos Relacionados (Código: FMF)

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Fonte oficial

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