FDA 510(k)

Astroglide Sensual Strawberry Personal Lubricant

Número K: K213671 · 2022-03-03

Data da decisão2022-03-03

Código do produtoNUC

Comité consultivoOB

DecisãoSubstantially Equivalent

Resumo do dispositivo

Astroglide Sensual Strawberry Personal Lubricant is the device name listed in this FDA 510(k) record. The listed applicant is Biofilm, Inc.. It received FDA 510(k) clearance on 2022-03-03 under 510(k) number K213671. 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 Astroglide Sensual Strawberry Personal Lubricant?

Astroglide Sensual Strawberry Personal Lubricant is a medical device that received FDA 510(k) clearance on 2022-03-03. The listed applicant is Biofilm, Inc.. The 510(k) number is K213671.

When did Astroglide Sensual Strawberry Personal Lubricant receive FDA 510(k) clearance?

Astroglide Sensual Strawberry Personal Lubricant received FDA 510(k) clearance on 2022-03-03, under 510(k) number K213671.

Who is the listed applicant for Astroglide Sensual Strawberry Personal Lubricant?

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

What is the FDA product code for Astroglide Sensual Strawberry Personal Lubricant?

The FDA product code for Astroglide Sensual Strawberry Personal Lubricant is NUC.

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Fonte oficial

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