FDA 510(k)

Insulin Pen Needle

Número K: K153706 · 2016-08-29

RequerenteSteriLance Medical (Suzhou), Inc.

Data da decisão2016-08-29

Código do produtoFMI

Comité consultivoHO

DecisãoSubstantially Equivalent

Resumo do dispositivo

Insulin Pen Needle is the device name listed in this FDA 510(k) record. The listed applicant is SteriLance Medical (Suzhou), Inc.. It received FDA 510(k) clearance on 2016-08-29 under 510(k) number K153706. The device is classified under product code FMI. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Insulin Pen Needle?

Insulin Pen Needle is a medical device that received FDA 510(k) clearance on 2016-08-29. The listed applicant is SteriLance Medical (Suzhou), Inc.. The 510(k) number is K153706.

When did Insulin Pen Needle receive FDA 510(k) clearance?

Insulin Pen Needle received FDA 510(k) clearance on 2016-08-29, under 510(k) number K153706.

Who is the listed applicant for Insulin Pen Needle?

The FDA 510(k) record lists SteriLance Medical (Suzhou), Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Insulin Pen Needle?

The FDA product code for Insulin Pen Needle is FMI.

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Dispositivos Relacionados (Código: FMI)

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Fonte oficial

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