FDA 510(k)

Sydney IVF Gamete Buffer

Número K: K153478 · 2016-08-15

RequerenteWilliam A. Cook Australia Pty. , Ltd.

Data da decisão2016-08-15

Código do produtoMQL

Comité consultivoOB

DecisãoSubstantially Equivalent

Resumo do dispositivo

Sydney IVF Gamete Buffer 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 2016-08-15 under 510(k) number K153478. The device is classified under product code MQL. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Sydney IVF Gamete Buffer?

Sydney IVF Gamete Buffer is a medical device that received FDA 510(k) clearance on 2016-08-15. The listed applicant is William A. Cook Australia Pty. , Ltd.. The 510(k) number is K153478.

When did Sydney IVF Gamete Buffer receive FDA 510(k) clearance?

Sydney IVF Gamete Buffer received FDA 510(k) clearance on 2016-08-15, under 510(k) number K153478.

Who is the listed applicant for Sydney IVF Gamete Buffer?

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 Sydney IVF Gamete Buffer?

The FDA product code for Sydney IVF Gamete Buffer is MQL.

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Fonte oficial

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