FDA 510(k)

Perpak™ Sterilization Tyvek Pouch

N.º K: K241123 · 2024-09-18

Fecha de decisión2024-09-18

Código de productoFRG

Comité asesorHO

DecisiónSubstantially Equivalent

Resumen del dispositivo

Perpak™ Sterilization Tyvek Pouch is the device name listed in this FDA 510(k) record. The listed applicant is Km Corp.. It received FDA 510(k) clearance on 2024-09-18 under 510(k) number K241123. 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 Perpak™ Sterilization Tyvek Pouch?

Perpak™ Sterilization Tyvek Pouch is a medical device that received FDA 510(k) clearance on 2024-09-18. The listed applicant is Km Corp.. The 510(k) number is K241123.

When did Perpak™ Sterilization Tyvek Pouch receive FDA 510(k) clearance?

Perpak™ Sterilization Tyvek Pouch received FDA 510(k) clearance on 2024-09-18, under 510(k) number K241123.

Who is the listed applicant for Perpak™ Sterilization Tyvek Pouch?

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

What is the FDA product code for Perpak™ Sterilization Tyvek Pouch?

The FDA product code for Perpak™ Sterilization Tyvek Pouch is FRG.

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Dispositivos relacionados (Código: FRG)

K261897HALYARD* ARMOR-FLEX* Sterilization Wrap with ASSURE-DRY* Technology; HALYARD* HEAVY-FLEX* Sterilization Wrap with ASSURE-DRY* Technology; HALYARD* STANDARD-FLEX* Sterilization Wrap with ASSURE-DRY* Technology; HALYARD* H300W Sterilization Wrap with ASSURE-DRY* TechnologyO&M Halyard, Inc.K252823Dukal Crepe Paper Sterilization WrapDukal, LLC K253454HALYARD* ONE-STEP* Sterilization Wrap; HALYARD* QUICK CHECK* Sterilization Wrap; HALYARD* SEQUENTIAL Sterilization Wrap; HALYARD* SMART-FOLD* Sterilization WrapO&M Halyard, Inc.K251347Sterilization Pouch/RollSterivic Medical Co., Ltd.K251177Self-Seal Sterilization Pouch and RollGuangdong Maidi Medical Co., Ltd.K250306Chex-All Sterilization Pouches and TubesPropper Manufacturing Co., Inc.

Fuente oficial

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