FDA 510(k)

Sterilization Pouch/Roll Made with Tyvek

N.º K: K180672 · 2018-06-06

SolicitanteSigma Medical Supplies Corporation

Fecha de decisión2018-06-06

Código de productoFRG

Comité asesorHO

DecisiónSubstantially Equivalent

Resumen del dispositivo

Sterilization Pouch/Roll Made with Tyvek is the device name listed in this FDA 510(k) record. The listed applicant is Sigma Medical Supplies Corporation. It received FDA 510(k) clearance on 2018-06-06 under 510(k) number K180672. The device is classified under product code FRG. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the Sterilization Pouch/Roll Made with Tyvek?

Sterilization Pouch/Roll Made with Tyvek is a medical device that received FDA 510(k) clearance on 2018-06-06. The listed applicant is Sigma Medical Supplies Corporation. The 510(k) number is K180672.

When did Sterilization Pouch/Roll Made with Tyvek receive FDA 510(k) clearance?

Sterilization Pouch/Roll Made with Tyvek received FDA 510(k) clearance on 2018-06-06, under 510(k) number K180672.

Who is the listed applicant for Sterilization Pouch/Roll Made with Tyvek?

The FDA 510(k) record lists Sigma Medical Supplies Corporation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Sterilization Pouch/Roll Made with Tyvek?

The FDA product code for Sterilization Pouch/Roll Made with Tyvek is FRG.

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Otros registros que enlistan a Sigma Medical Supplies Corporation como solicitante

K202462SIGMA Sterilization Pouch and Roll

Dispositivos relacionados (Código: FRG)

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Fuente oficial

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