FDA 510(k)

Prometheus ChitoGauze XR PRO

N.º K: K153582 · 2016-05-25

SolicitanteHem Con Medical Technologies, Inc.

Fecha de decisión2016-05-25

Código de productoQSY

DecisiónSubstantially Equivalent

Resumen del dispositivo

Prometheus ChitoGauze XR PRO is the device name listed in this FDA 510(k) record. The listed applicant is Hem Con Medical Technologies, Inc.. It received FDA 510(k) clearance on 2016-05-25 under 510(k) number K153582. The device is classified under product code QSY. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the Prometheus ChitoGauze XR PRO?

Prometheus ChitoGauze XR PRO is a medical device that received FDA 510(k) clearance on 2016-05-25. The listed applicant is Hem Con Medical Technologies, Inc.. The 510(k) number is K153582.

When did Prometheus ChitoGauze XR PRO receive FDA 510(k) clearance?

Prometheus ChitoGauze XR PRO received FDA 510(k) clearance on 2016-05-25, under 510(k) number K153582.

Who is the listed applicant for Prometheus ChitoGauze XR PRO?

The FDA 510(k) record lists Hem Con Medical Technologies, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Prometheus ChitoGauze XR PRO?

The FDA product code for Prometheus ChitoGauze XR PRO is QSY.

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