FDA 510(k)

Trojan Supra Lubricated Polyurethane Male Condom

N.º K: K171639 · 2017-08-01

Fecha de decisión2017-08-01

Código de productoMOL

Comité asesorOB

DecisiónSubstantially Equivalent

Resumen del dispositivo

Trojan Supra Lubricated Polyurethane Male Condom is the device name listed in this FDA 510(k) record. The listed applicant is Church & Dwight Co., Inc.. It received FDA 510(k) clearance on 2017-08-01 under 510(k) number K171639. The device is classified under product code MOL. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the Trojan Supra Lubricated Polyurethane Male Condom?

Trojan Supra Lubricated Polyurethane Male Condom is a medical device that received FDA 510(k) clearance on 2017-08-01. The listed applicant is Church & Dwight Co., Inc.. The 510(k) number is K171639.

When did Trojan Supra Lubricated Polyurethane Male Condom receive FDA 510(k) clearance?

Trojan Supra Lubricated Polyurethane Male Condom received FDA 510(k) clearance on 2017-08-01, under 510(k) number K171639.

Who is the listed applicant for Trojan Supra Lubricated Polyurethane Male Condom?

The FDA 510(k) record lists Church & Dwight Co., Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Trojan Supra Lubricated Polyurethane Male Condom?

The FDA product code for Trojan Supra Lubricated Polyurethane Male Condom is MOL.

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Otros registros que enlistan a Church & Dwight Co., Inc. como solicitante

K243640Trojan™ Ultra Ribbed Ecstasy latex condom with lubricant (Trojan™ Ultra Ribbed Ecstasy)K240379TROJAN SIS Synthetic Latex Condom with Silicone Lubricant K221906TROJAN Fire & Ice lubricated male natural rubber latex condom K221431TROJAN(TM) Her Pleasure Warming male natural rubber latex condom with warming lubricant K203818Replens Long-Lasting Vaginal Moisturizer K193450Pre-Seed™ Fertility Lubricant

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Dispositivos relacionados (Código: MOL)

K252158Sagami Original 002 Polyurethane Male CondomMayer Laboratories K243967ONE Nitrile CondomGlobal Protection Corp.K241617Durex Polyisoprene CondomRb Health (Us), LLC K240379TROJAN SIS Synthetic Latex Condom with Silicone LubricantChurch & Dwight Co., Inc.K240896ONE Nitrile CondomGlobal Protection Corp.K232470Polyisoprene Extra Large CondomSuretex Limited

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.