FDA 510(k)

Premium Plus Prophy Air Motor

N.º K: K170261 · 2017-10-19

SolicitantePremium Plus International Limited

Fecha de decisión2017-10-19

Código de productoEFB

Comité asesorDE

DecisiónSubstantially Equivalent

Resumen del dispositivo

Premium Plus Prophy Air Motor is the device name listed in this FDA 510(k) record. The listed applicant is Premium Plus International Limited. It received FDA 510(k) clearance on 2017-10-19 under 510(k) number K170261. The device is classified under product code EFB. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the Premium Plus Prophy Air Motor?

Premium Plus Prophy Air Motor is a medical device that received FDA 510(k) clearance on 2017-10-19. The listed applicant is Premium Plus International Limited. The 510(k) number is K170261.

When did Premium Plus Prophy Air Motor receive FDA 510(k) clearance?

Premium Plus Prophy Air Motor received FDA 510(k) clearance on 2017-10-19, under 510(k) number K170261.

Who is the listed applicant for Premium Plus Prophy Air Motor?

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

What is the FDA product code for Premium Plus Prophy Air Motor?

The FDA product code for Premium Plus Prophy Air Motor is EFB.

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Fuente oficial

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