FDA 510(k)

Double Lumen Ovum Aspiration Needles

Número K: K171611 · 2017-12-15

RequerenteWilliam A. Cook Australia Pty. , Ltd.

Data da decisão2017-12-15

Código do produtoMQE

Comité consultivoOB

DecisãoSubstantially Equivalent

Resumo do dispositivo

Double Lumen Ovum Aspiration Needles is the device name listed in this FDA 510(k) record. The listed applicant is William A. Cook Australia Pty. , Ltd.. It received FDA 510(k) clearance on 2017-12-15 under 510(k) number K171611. The device is classified under product code MQE. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Double Lumen Ovum Aspiration Needles?

Double Lumen Ovum Aspiration Needles is a medical device that received FDA 510(k) clearance on 2017-12-15. The listed applicant is William A. Cook Australia Pty. , Ltd.. The 510(k) number is K171611.

When did Double Lumen Ovum Aspiration Needles receive FDA 510(k) clearance?

Double Lumen Ovum Aspiration Needles received FDA 510(k) clearance on 2017-12-15, under 510(k) number K171611.

Who is the listed applicant for Double Lumen Ovum Aspiration Needles?

The FDA 510(k) record lists William A. Cook Australia Pty. , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Double Lumen Ovum Aspiration Needles?

The FDA product code for Double Lumen Ovum Aspiration Needles is MQE.

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Fonte oficial

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