FDA 510(k)

Dispositivo de Herbst de Acrílico con Grabador Micro

N.º K: K170606 · 2017-11-16

Fecha de decisión2017-11-16

Código de productoPLC

Comité asesorDE

DecisiónSubstantially Equivalent

Resumen del dispositivo

Acrylic Herbst Appliance with Micro-Recorder is the device name listed in this FDA 510(k) record. The listed applicant is Gergen'S Orthodontic Lab. It received FDA 510(k) clearance on 2017-11-16 under 510(k) number K170606. The device is classified under product code PLC. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the Acrylic Herbst Appliance with Micro-Recorder?

Acrylic Herbst Appliance with Micro-Recorder is a medical device that received FDA 510(k) clearance on 2017-11-16. The listed applicant is Gergen'S Orthodontic Lab. The 510(k) number is K170606.

When did Acrylic Herbst Appliance with Micro-Recorder receive FDA 510(k) clearance?

Acrylic Herbst Appliance with Micro-Recorder received FDA 510(k) clearance on 2017-11-16, under 510(k) number K170606.

Who is the listed applicant for Acrylic Herbst Appliance with Micro-Recorder?

The FDA 510(k) record lists Gergen'S Orthodontic Lab as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Acrylic Herbst Appliance with Micro-Recorder?

The FDA product code for Acrylic Herbst Appliance with Micro-Recorder is PLC.

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Fuente oficial

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