FDA 510(k)

Flip Lube

Número K: K171516 · 2018-02-05

Data da decisão2018-02-05

Código do produtoNUC

Comité consultivoOB

DecisãoSubstantially Equivalent

Resumo do dispositivo

Flip Lube is the device name listed in this FDA 510(k) record. The listed applicant is Imquest Biosciences, Inc.. It received FDA 510(k) clearance on 2018-02-05 under 510(k) number K171516. The device is classified under product code NUC. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Flip Lube?

Flip Lube is a medical device that received FDA 510(k) clearance on 2018-02-05. The listed applicant is Imquest Biosciences, Inc.. The 510(k) number is K171516.

When did Flip Lube receive FDA 510(k) clearance?

Flip Lube received FDA 510(k) clearance on 2018-02-05, under 510(k) number K171516.

Who is the listed applicant for Flip Lube?

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

What is the FDA product code for Flip Lube?

The FDA product code for Flip Lube is NUC.

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Fonte oficial

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