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FDA 510(k)

aoni Natural Rubber Latex Condom

Número K: K153016 · 2016-10-20

RequerenteGuangzhou Daming United Rubber Products , Ltd.
Data da decisão2016-10-20
Código do produtoHIS
Comité consultivoOB
DecisãoSubstantially Equivalent

Resumo do dispositivo

aoni Natural Rubber Latex Condom is the device name listed in this FDA 510(k) record. The listed applicant is Guangzhou Daming United Rubber Products , Ltd.. It received FDA 510(k) clearance on 2016-10-20 under 510(k) number K153016. 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 aoni Natural Rubber Latex Condom?

aoni Natural Rubber Latex Condom is a medical device that received FDA 510(k) clearance on 2016-10-20. The listed applicant is Guangzhou Daming United Rubber Products , Ltd.. The 510(k) number is K153016.

When did aoni Natural Rubber Latex Condom receive FDA 510(k) clearance?

aoni Natural Rubber Latex Condom received FDA 510(k) clearance on 2016-10-20, under 510(k) number K153016.

Who is the listed applicant for aoni Natural Rubber Latex Condom?

The FDA 510(k) record lists Guangzhou Daming United Rubber Products , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for aoni Natural Rubber Latex Condom?

The FDA product code for aoni Natural Rubber Latex Condom is HIS.

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Dispositivos Relacionados (Código: HIS)

Registros relacionados são pareados automaticamente usando nomes, códigos de produtos ou outros metadados. Um pareamento não estabelece um vínculo clínico, científico, corporativo ou regulatório verificado; revise as fontes oficiais vinculadas.

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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