FDA 510(k)

SILICONE Personal Lubricant

Numéro K : K191654 · 2020-04-14

DemandeurBath Concept Cosmetics (Dongguan) Co., Ltd.

Date de décision2020-04-14

Code produitNUC

Comité consultatifOB

DécisionSubstantially Equivalent

Résumé du dispositif

SILICONE Personal Lubricant is the device name listed in this FDA 510(k) record. The listed applicant is Bath Concept Cosmetics (Dongguan) Co., Ltd.. It received FDA 510(k) clearance on 2020-04-14 under 510(k) number K191654. The device is classified under product code NUC. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Questions fréquentes

What is the SILICONE Personal Lubricant?

SILICONE Personal Lubricant is a medical device that received FDA 510(k) clearance on 2020-04-14. The listed applicant is Bath Concept Cosmetics (Dongguan) Co., Ltd.. The 510(k) number is K191654.

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

SILICONE Personal Lubricant received FDA 510(k) clearance on 2020-04-14, under 510(k) number K191654.

Who is the listed applicant for SILICONE Personal Lubricant?

The FDA 510(k) record lists Bath Concept Cosmetics (Dongguan) Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SILICONE Personal Lubricant?

The FDA product code for SILICONE Personal Lubricant is NUC.

Essais cliniques associés

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Dispositifs connexes (Code : NUC)

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Source officielle

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