FDA 510(k)

Steriking LT-Blueline Pouches with Tyvek

N.º K: K221379 · 2023-01-04

Fecha de decisión2023-01-04

Código de productoFRG

Comité asesorHO

DecisiónSubstantially Equivalent

Resumen del dispositivo

Steriking LT-Blueline Pouches with Tyvek is the device name listed in this FDA 510(k) record. The listed applicant is Wipak OY. It received FDA 510(k) clearance on 2023-01-04 under 510(k) number K221379. 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 Steriking LT-Blueline Pouches with Tyvek?

Steriking LT-Blueline Pouches with Tyvek is a medical device that received FDA 510(k) clearance on 2023-01-04. The listed applicant is Wipak OY. The 510(k) number is K221379.

When did Steriking LT-Blueline Pouches with Tyvek receive FDA 510(k) clearance?

Steriking LT-Blueline Pouches with Tyvek received FDA 510(k) clearance on 2023-01-04, under 510(k) number K221379.

Who is the listed applicant for Steriking LT-Blueline Pouches with Tyvek?

The FDA 510(k) record lists Wipak OY as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Steriking LT-Blueline Pouches with Tyvek?

The FDA product code for Steriking LT-Blueline Pouches with Tyvek is FRG.

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Otros registros que enlistan a Wipak OY como solicitante

K232625Steriking® Pouch for Robotic Instruments K231999Steriking® LT-Blueline Pouches with Tyvek®K231996Steriking® LT-Blueline Pouches with Tyvek®K221377SteriKing LT-Blueline Pouches with Tyvek K221016Steriking Packaging for Medical Devices K210810Steiking Packaging for Medical Devices

Ver todos los 7 dispositivos →

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Fuente oficial

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