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FDA 510(k)

Cistoscopio Vesair 0 grados, Cistoscopio Vesair 30 grados Largo, Cistoscopio Vesair 70 grados Largo, Cistoscopio Vesair 30 grados, Cistoscopio Vesair 70 grados

N.º K: K170862 · 2017-12-19

SolicitanteSolace Therapeutics, Inc.
Fecha de decisión2017-12-19
Código de productoFAJ
Comité asesorGU
DecisiónSubstantially Equivalent

Resumen del dispositivo

Vesair 0 degree Cystoscope, Vesair 30 degree Long Cystoscope, Vesair 70 degree Long Cystoscope,Vesair 30 degree Cystoscope,Vesair 70 degree Cystoscope is the device name listed in this FDA 510(k) record. The listed applicant is Solace Therapeutics, Inc.. It received FDA 510(k) clearance on 2017-12-19 under 510(k) number K170862. The device is classified under product code FAJ. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the Vesair 0 degree Cystoscope, Vesair 30 degree Long Cystoscope, Vesair 70 degree Long Cystoscope,Vesair 30 degree Cystoscope,Vesair 70 degree Cystoscope?

Vesair 0 degree Cystoscope, Vesair 30 degree Long Cystoscope, Vesair 70 degree Long Cystoscope,Vesair 30 degree Cystoscope,Vesair 70 degree Cystoscope is a medical device that received FDA 510(k) clearance on 2017-12-19. The listed applicant is Solace Therapeutics, Inc.. The 510(k) number is K170862.

When did Vesair 0 degree Cystoscope, Vesair 30 degree Long Cystoscope, Vesair 70 degree Long Cystoscope,Vesair 30 degree Cystoscope,Vesair 70 degree Cystoscope receive FDA 510(k) clearance?

Vesair 0 degree Cystoscope, Vesair 30 degree Long Cystoscope, Vesair 70 degree Long Cystoscope,Vesair 30 degree Cystoscope,Vesair 70 degree Cystoscope received FDA 510(k) clearance on 2017-12-19, under 510(k) number K170862.

Who is the listed applicant for Vesair 0 degree Cystoscope, Vesair 30 degree Long Cystoscope, Vesair 70 degree Long Cystoscope,Vesair 30 degree Cystoscope,Vesair 70 degree Cystoscope?

The FDA 510(k) record lists Solace Therapeutics, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Vesair 0 degree Cystoscope, Vesair 30 degree Long Cystoscope, Vesair 70 degree Long Cystoscope,Vesair 30 degree Cystoscope,Vesair 70 degree Cystoscope?

The FDA product code for Vesair 0 degree Cystoscope, Vesair 30 degree Long Cystoscope, Vesair 70 degree Long Cystoscope,Vesair 30 degree Cystoscope,Vesair 70 degree Cystoscope is FAJ.

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Dispositivos relacionados (Código: FAJ)

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Fuente oficial

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