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FDA 510(k)

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

N.º K: K191480 · 2019-10-11

Fecha de decisión2019-10-11
Código de productoNUC
Comité asesorOB
DecisiónSubstantially Equivalent

Resumen del 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.

Preguntas frecuentes

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.

Ensayos clínicos relacionados

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.

Dispositivos relacionados (Código: NUC)

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.

Fuente oficial

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