FDA 510(k)

Single Lumen Ovum Aspiration Needles

Número K: K171625 · 2018-01-12

RequerenteWillian A. Cook Australia Pty, Ltd.

Data da decisão2018-01-12

Código do produtoMQE

Comité consultivoOB

DecisãoSubstantially Equivalent

Resumo do dispositivo

Single Lumen Ovum Aspiration Needles is the device name listed in this FDA 510(k) record. The listed applicant is Willian A. Cook Australia Pty, Ltd.. It received FDA 510(k) clearance on 2018-01-12 under 510(k) number K171625. 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 Single Lumen Ovum Aspiration Needles?

Single Lumen Ovum Aspiration Needles is a medical device that received FDA 510(k) clearance on 2018-01-12. The listed applicant is Willian A. Cook Australia Pty, Ltd.. The 510(k) number is K171625.

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

Single Lumen Ovum Aspiration Needles received FDA 510(k) clearance on 2018-01-12, under 510(k) number K171625.

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

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

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

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

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Fonte oficial

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