FDA 510(k)

Bucked Stride Silicone Lubricant, #LubeLife Thin Silicone Lubricant, JO XTRA SILKY Ultra-Thin Silicone Personal Lubricant

Numéro K : K190858 · 2019-09-18

Date de décision2019-09-18

Code produitNUC

Comité consultatifOB

DécisionSubstantially Equivalent

Résumé du dispositif

Bucked Stride Silicone Lubricant, #LubeLife Thin Silicone Lubricant, JO XTRA SILKY Ultra-Thin Silicone Personal Lubricant is the device name listed in this FDA 510(k) record. The listed applicant is United Consortium. It received FDA 510(k) clearance on 2019-09-18 under 510(k) number K190858. 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 Bucked Stride Silicone Lubricant, #LubeLife Thin Silicone Lubricant, JO XTRA SILKY Ultra-Thin Silicone Personal Lubricant?

Bucked Stride Silicone Lubricant, #LubeLife Thin Silicone Lubricant, JO XTRA SILKY Ultra-Thin Silicone Personal Lubricant is a medical device that received FDA 510(k) clearance on 2019-09-18. The listed applicant is United Consortium. The 510(k) number is K190858.

When did Bucked Stride Silicone Lubricant, #LubeLife Thin Silicone Lubricant, JO XTRA SILKY Ultra-Thin Silicone Personal Lubricant receive FDA 510(k) clearance?

Bucked Stride Silicone Lubricant, #LubeLife Thin Silicone Lubricant, JO XTRA SILKY Ultra-Thin Silicone Personal Lubricant received FDA 510(k) clearance on 2019-09-18, under 510(k) number K190858.

Who is the listed applicant for Bucked Stride Silicone Lubricant, #LubeLife Thin Silicone Lubricant, JO XTRA SILKY Ultra-Thin Silicone Personal Lubricant?

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

What is the FDA product code for Bucked Stride Silicone Lubricant, #LubeLife Thin Silicone Lubricant, JO XTRA SILKY Ultra-Thin Silicone Personal Lubricant?

The FDA product code for Bucked Stride Silicone Lubricant, #LubeLife Thin Silicone Lubricant, JO XTRA SILKY Ultra-Thin Silicone Personal Lubricant is NUC.

Essais cliniques associés

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Source officielle

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