FDA 510(k)

Smile Makers Personal Lubricant

N.º K: K182100 · 2019-04-25

Fecha de decisión2019-04-25

Código de productoNUC

Comité asesorOB

DecisiónSubstantially Equivalent

Resumen del dispositivo

Smile Makers Personal Lubricant is the device name listed in this FDA 510(k) record. The listed applicant is Lfbeauty (Thailand) Limited. It received FDA 510(k) clearance on 2019-04-25 under 510(k) number K182100. The device is classified under product code NUC. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the Smile Makers Personal Lubricant?

Smile Makers Personal Lubricant is a medical device that received FDA 510(k) clearance on 2019-04-25. The listed applicant is Lfbeauty (Thailand) Limited. The 510(k) number is K182100.

When did Smile Makers Personal Lubricant receive FDA 510(k) clearance?

Smile Makers Personal Lubricant received FDA 510(k) clearance on 2019-04-25, under 510(k) number K182100.

Who is the listed applicant for Smile Makers Personal Lubricant?

The FDA 510(k) record lists Lfbeauty (Thailand) Limited as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Smile Makers Personal Lubricant?

The FDA product code for Smile Makers Personal Lubricant is NUC.

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Fuente oficial

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