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FDA 510(k)

Wet Water Based Personal Lubricant (additionally, branded as WET Platinum Houston, Elite Water-Based Hybrid)

Número K: K191480 · 2019-10-11

Data da decisão2019-10-11
Código do produtoNUC
Comité consultivoOB
DecisãoSubstantially Equivalent

Resumo do dispositivo

Wet Water Based Personal Lubricant (additionally, branded as WET Platinum Houston, Elite Water-Based Hybrid) is the device name listed in this FDA 510(k) record. The listed applicant is Trigg Laboratories, Inc. D/B/A Wet International. It received FDA 510(k) clearance on 2019-10-11 under 510(k) number K191480. The device is classified under product code NUC. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Wet Water Based Personal Lubricant (additionally, branded as WET Platinum Houston, Elite Water-Based Hybrid)?

Wet Water Based Personal Lubricant (additionally, branded as WET Platinum Houston, Elite Water-Based Hybrid) is a medical device that received FDA 510(k) clearance on 2019-10-11. The listed applicant is Trigg Laboratories, Inc. D/B/A Wet International. The 510(k) number is K191480.

When did Wet Water Based Personal Lubricant (additionally, branded as WET Platinum Houston, Elite Water-Based Hybrid) receive FDA 510(k) clearance?

Wet Water Based Personal Lubricant (additionally, branded as WET Platinum Houston, Elite Water-Based Hybrid) received FDA 510(k) clearance on 2019-10-11, under 510(k) number K191480.

Who is the listed applicant for Wet Water Based Personal Lubricant (additionally, branded as WET Platinum Houston, Elite Water-Based Hybrid)?

The FDA 510(k) record lists Trigg Laboratories, Inc. D/B/A Wet International as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Wet Water Based Personal Lubricant (additionally, branded as WET Platinum Houston, Elite Water-Based Hybrid)?

The FDA product code for Wet Water Based Personal Lubricant (additionally, branded as WET Platinum Houston, Elite Water-Based Hybrid) is NUC.

Ensaios clínicos relacionados

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.

Dispositivos Relacionados (Código: NUC)

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.

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