FDA 510(k)

JO Premium Jelly Original Personal Lubricant

N.º K: K191214 · 2019-08-01

Fecha de decisión2019-08-01

Código de productoNUC

Comité asesorOB

DecisiónSubstantially Equivalent

Resumen del dispositivo

JO Premium Jelly Original 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 2019-08-01 under 510(k) number K191214. 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 JO Premium Jelly Original Personal Lubricant?

JO Premium Jelly Original Personal Lubricant is a medical device that received FDA 510(k) clearance on 2019-08-01. The listed applicant is United Consortium. The 510(k) number is K191214.

When did JO Premium Jelly Original Personal Lubricant receive FDA 510(k) clearance?

JO Premium Jelly Original Personal Lubricant received FDA 510(k) clearance on 2019-08-01, under 510(k) number K191214.

Who is the listed applicant for JO Premium Jelly Original 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 JO Premium Jelly Original Personal Lubricant?

The FDA product code for JO Premium Jelly Original Personal Lubricant is NUC.

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Otros registros que enlistan a United Consortium como solicitante

K192203JO for Him H2O Gel Original Personal Lubricant K190858Bucked Stride Silicone Lubricant, #LubeLife Thin Silicone Lubricant, JO XTRA SILKY Ultra-Thin Silicone Personal Lubricant K182585JO Actively Trying Personal Lubricant K183584JO H2O Jelly Original Personal Lubricant K183384JO Agape Original Personal Lubricant, MUSE Essence Water-Based Lubricant, #LubeLife Water-Based Lubricant, #LubeLife Water-Based Anal Lubricant K182105JO Naturalove Personal Lubricant, JO Naturalove Strawberry Fields Flavored Personal Lubricant

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Dispositivos relacionados (Código: NUC)

K260117EverslideSpecial Situations, LLC K253989HARU Orgasm by jack herer water based lubricant (WL-OJ); HARU Orgasm water based lubricant (WL-OR); HARU STEAMY water based lubricant (WL-ST)Maxigen Biotech, Inc.K261905BUM OilBumlicious, LLC (DBA “Bumlicious”)K261177PINKSLIP Water-Based Personal Lubricant and MoisturizerPINKSLIP, LLC K261909Plum Vagiceuticals™ Vaginal Moisturizing SuppositoriesPCCA, Inc.K254011Flow Water-Based Personal LubricantLBDO Group, Inc.

Fuente oficial

Ver en la base de datos de la FDA →

Datos procedentes de la API abierta de la FDA. Para obtener la información más actualizada y autoritativa, consulte siempre el registro oficial.