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FDA 510(k)

Trojan XOXO Ribbed Male Natural Rubber Latex Condom with Silicone and Aloe Lubricant

Número K: K161915 · 2016-09-09

RequerenteChurch & Dwight Co., Inc.
Data da decisão2016-09-09
Código do produtoHIS
Comité consultivoOB
DecisãoSubstantially Equivalent

Resumo do dispositivo

Trojan XOXO Ribbed Male Natural Rubber Latex Condom with Silicone and Aloe Lubricant 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 2016-09-09 under 510(k) number K161915. The device is classified under product code HIS. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Trojan XOXO Ribbed Male Natural Rubber Latex Condom with Silicone and Aloe Lubricant?

Trojan XOXO Ribbed Male Natural Rubber Latex Condom with Silicone and Aloe Lubricant is a medical device that received FDA 510(k) clearance on 2016-09-09. The listed applicant is Church & Dwight Co., Inc.. The 510(k) number is K161915.

When did Trojan XOXO Ribbed Male Natural Rubber Latex Condom with Silicone and Aloe Lubricant receive FDA 510(k) clearance?

Trojan XOXO Ribbed Male Natural Rubber Latex Condom with Silicone and Aloe Lubricant received FDA 510(k) clearance on 2016-09-09, under 510(k) number K161915.

Who is the listed applicant for Trojan XOXO Ribbed Male Natural Rubber Latex Condom with Silicone and Aloe Lubricant?

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 XOXO Ribbed Male Natural Rubber Latex Condom with Silicone and Aloe Lubricant?

The FDA product code for Trojan XOXO Ribbed Male Natural Rubber Latex Condom with Silicone and Aloe Lubricant is HIS.

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Dispositivos Relacionados (Código: HIS)

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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.

Fonte oficial

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