FDA 510(k)

GBR system

N.º K: K170697 · 2018-05-24

Fecha de decisión2018-05-24

Código de productoJEY

Comité asesorDE

DecisiónSubstantially Equivalent

Resumen del dispositivo

GBR system is the device name listed in this FDA 510(k) record. The listed applicant is Surgident. It received FDA 510(k) clearance on 2018-05-24 under 510(k) number K170697. The device is classified under product code JEY. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the GBR system?

GBR system is a medical device that received FDA 510(k) clearance on 2018-05-24. The listed applicant is Surgident. The 510(k) number is K170697.

When did GBR system receive FDA 510(k) clearance?

GBR system received FDA 510(k) clearance on 2018-05-24, under 510(k) number K170697.

Who is the listed applicant for GBR system?

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

What is the FDA product code for GBR system?

The FDA product code for GBR system is JEY.

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Fuente oficial

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