FDA 510(k)

ProTEC-USA EZDoff Gown

N.º K: K210405 · 2021-12-15

Fecha de decisión2021-12-15

Código de productoQPC

Comité asesorSU

DecisiónSubstantially Equivalent

Resumen del dispositivo

ProTEC-USA EZDoff Gown is the device name listed in this FDA 510(k) record. The listed applicant is Cadillac Products, Inc.. It received FDA 510(k) clearance on 2021-12-15 under 510(k) number K210405. The device is classified under product code QPC. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the ProTEC-USA EZDoff Gown?

ProTEC-USA EZDoff Gown is a medical device that received FDA 510(k) clearance on 2021-12-15. The listed applicant is Cadillac Products, Inc.. The 510(k) number is K210405.

When did ProTEC-USA EZDoff Gown receive FDA 510(k) clearance?

ProTEC-USA EZDoff Gown received FDA 510(k) clearance on 2021-12-15, under 510(k) number K210405.

Who is the listed applicant for ProTEC-USA EZDoff Gown?

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

What is the FDA product code for ProTEC-USA EZDoff Gown?

The FDA product code for ProTEC-USA EZDoff Gown is QPC.

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Dispositivos relacionados (Código: QPC)

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Fuente oficial

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