FDA 510(k)

Memodyn Staple

N.º K: K161587 · 2017-02-01

SolicitanteAustin & Associates, Inc./Telos Medical Equipment

Fecha de decisión2017-02-01

Código de productoJDR

Comité asesorOR

DecisiónSubstantially Equivalent

Resumen del dispositivo

Memodyn Staple is the device name listed in this FDA 510(k) record. The listed applicant is Austin & Associates, Inc./Telos Medical Equipment. It received FDA 510(k) clearance on 2017-02-01 under 510(k) number K161587. The device is classified under product code JDR. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the Memodyn Staple?

Memodyn Staple is a medical device that received FDA 510(k) clearance on 2017-02-01. The listed applicant is Austin & Associates, Inc./Telos Medical Equipment. The 510(k) number is K161587.

When did Memodyn Staple receive FDA 510(k) clearance?

Memodyn Staple received FDA 510(k) clearance on 2017-02-01, under 510(k) number K161587.

Who is the listed applicant for Memodyn Staple?

The FDA 510(k) record lists Austin & Associates, Inc./Telos Medical Equipment as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Memodyn Staple?

The FDA product code for Memodyn Staple is JDR.

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Fuente oficial

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