FDA 510(k)

Ah!Yes Ob Coco Lubrificante Pessoal

Número K: K191411 · 2020-02-06

Data da decisão2020-02-06

Código do produtoNUC

Comité consultivoOB

DecisãoSubstantially Equivalent

Resumo do dispositivo

Ah!Yes Ob Coco Personal Lubricant is the device name listed in this FDA 510(k) record. The listed applicant is Bio-Tech Lubricants, Ltd.. It received FDA 510(k) clearance on 2020-02-06 under 510(k) number K191411. 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 Ah!Yes Ob Coco Personal Lubricant?

Ah!Yes Ob Coco Personal Lubricant is a medical device that received FDA 510(k) clearance on 2020-02-06. The listed applicant is Bio-Tech Lubricants, Ltd.. The 510(k) number is K191411.

When did Ah!Yes Ob Coco Personal Lubricant receive FDA 510(k) clearance?

Ah!Yes Ob Coco Personal Lubricant received FDA 510(k) clearance on 2020-02-06, under 510(k) number K191411.

Who is the listed applicant for Ah!Yes Ob Coco Personal Lubricant?

The FDA 510(k) record lists Bio-Tech Lubricants, Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Ah!Yes Ob Coco Personal Lubricant?

The FDA product code for Ah!Yes Ob Coco Personal Lubricant is NUC.

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