FDA 510(k)

Steriking® LT-Blueline Pouches with Tyvek®

N.º K: K231996 · 2023-09-07

Fecha de decisión2023-09-07

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 2023-09-07 under 510(k) number K231996. 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 2023-09-07. The listed applicant is Wipak OY. The 510(k) number is K231996.

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 2023-09-07, under 510(k) number K231996.

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®K221379Steriking 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 →

Dispositivos relacionados (Código: FRG)

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Fuente oficial

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