FDA 510(k)

SIGMA Sterilization Pouch and Roll

N.º K: K180661 · 2018-06-05

Fecha de decisión2018-06-05

Código de productoFRG

Comité asesorHO

DecisiónSubstantially Equivalent

Resumen del dispositivo

SIGMA Sterilization Pouch and Roll is the device name listed in this FDA 510(k) record. The listed applicant is Sigma Medical Supplies Corp.. It received FDA 510(k) clearance on 2018-06-05 under 510(k) number K180661. 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 SIGMA Sterilization Pouch and Roll?

SIGMA Sterilization Pouch and Roll is a medical device that received FDA 510(k) clearance on 2018-06-05. The listed applicant is Sigma Medical Supplies Corp.. The 510(k) number is K180661.

When did SIGMA Sterilization Pouch and Roll receive FDA 510(k) clearance?

SIGMA Sterilization Pouch and Roll received FDA 510(k) clearance on 2018-06-05, under 510(k) number K180661.

Who is the listed applicant for SIGMA Sterilization Pouch and Roll?

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

What is the FDA product code for SIGMA Sterilization Pouch and Roll?

The FDA product code for SIGMA Sterilization Pouch and Roll is FRG.

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Dispositivos relacionados (Código: FRG)

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Fuente oficial

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