FDA 510(k)

LUBi Water Based Personal Lubricant

Número K: K203257 · 2020-12-23

Data da decisão2020-12-23

Código do produtoNUC

Comité consultivoOB

DecisãoSubstantially Equivalent

Resumo do dispositivo

LUBi Water Based Personal Lubricant is the device name listed in this FDA 510(k) record. The listed applicant is Boya Biotechnology Co., Ltd.. It received FDA 510(k) clearance on 2020-12-23 under 510(k) number K203257. 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 LUBi Water Based Personal Lubricant?

LUBi Water Based Personal Lubricant is a medical device that received FDA 510(k) clearance on 2020-12-23. The listed applicant is Boya Biotechnology Co., Ltd.. The 510(k) number is K203257.

When did LUBi Water Based Personal Lubricant receive FDA 510(k) clearance?

LUBi Water Based Personal Lubricant received FDA 510(k) clearance on 2020-12-23, under 510(k) number K203257.

Who is the listed applicant for LUBi Water Based Personal Lubricant?

The FDA 510(k) record lists Boya Biotechnology Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for LUBi Water Based Personal Lubricant?

The FDA product code for LUBi Water Based Personal Lubricant is NUC.

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