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FDA 510(k)

JUD custom fit condom

N.º K: K172414 · 2017-10-12

SolicitanteGlobal Mailer Partners, LLC
Fecha de decisión2017-10-12
Código de productoHIS
Comité asesorOB
DecisiónSubstantially Equivalent

Resumen del dispositivo

JUD custom fit condom is the device name listed in this FDA 510(k) record. The listed applicant is Global Mailer Partners, LLC. It received FDA 510(k) clearance on 2017-10-12 under 510(k) number K172414. The device is classified under product code HIS. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the JUD custom fit condom?

JUD custom fit condom is a medical device that received FDA 510(k) clearance on 2017-10-12. The listed applicant is Global Mailer Partners, LLC. The 510(k) number is K172414.

When did JUD custom fit condom receive FDA 510(k) clearance?

JUD custom fit condom received FDA 510(k) clearance on 2017-10-12, under 510(k) number K172414.

Who is the listed applicant for JUD custom fit condom?

The FDA 510(k) record lists Global Mailer Partners, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for JUD custom fit condom?

The FDA product code for JUD custom fit condom is HIS.

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Dispositivos relacionados (Código: HIS)

Los registros relacionados se emparejan automáticamente mediante nombres, códigos de producto u otros metadatos. Un emparejamiento no establece una relación clínica, científica, corporativa o regulatoria verificada; revise las fuentes oficiales enlazadas.

K262108FAMA Male Latex Condoms – Aqueous Lubricant (Ultra-thin);FAMA Male Latex Condoms – Aqueous Lubricant (Plain);FAMA Male Latex Condoms – Aqueous Lubricant (Ribbed);FAMA Male Latex Condoms – Aqueous Lubricant (Dotted);FAMA Male Latex Condoms – Aqueous Lubricant (Non-regular Shaped);MO Male Latex Condoms – Aqueous Lubricant (Ultra-thin);MO Male Latex Condoms – Aqueous Lubricant (Plain);MO Male Latex Condoms – Aqueous Lubricant (Ribbed);MO Male Latex Condoms – Aqueous Lubricant (Dotted);MOShanghai Personage Hygiene Products Co., Ltd.K252622Male Latex Condom HAOkamoto USA, Inc.K252521LifeStyles® HydraFeel Natural Rubber Latex CondomSuretex LimitedK250034Natural rubber latex male condomShaoguan Regenex Pharmaceuticals Co., Ltd.K243421Lelo Hex Lubricated Natural Rubber Latex CondomLelo, Inc.K243640Trojan™ Ultra Ribbed Ecstasy latex condom with lubricant (Trojan™ Ultra Ribbed Ecstasy)Church & Dwight Co., 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.

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