FDA 510(k)

Astroglide X Silicone Personal Lubricant

Número K: K210242 · 2021-04-28

Data da decisão2021-04-28

Código do produtoNUC

Comité consultivoOB

DecisãoSubstantially Equivalent

Resumo do dispositivo

Astroglide X Silicone 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 2021-04-28 under 510(k) number K210242. 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 X Silicone Personal Lubricant?

Astroglide X Silicone Personal Lubricant is a medical device that received FDA 510(k) clearance on 2021-04-28. The listed applicant is Biofilm, Inc.. The 510(k) number is K210242.

When did Astroglide X Silicone Personal Lubricant receive FDA 510(k) clearance?

Astroglide X Silicone Personal Lubricant received FDA 510(k) clearance on 2021-04-28, under 510(k) number K210242.

Who is the listed applicant for Astroglide X Silicone 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 X Silicone Personal Lubricant?

The FDA product code for Astroglide X Silicone Personal Lubricant is NUC.

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Fonte oficial

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