FDA 510(k)

Cardinal Health Sterilization Wrap

Número K: K161910 · 2017-04-20

Data da decisão2017-04-20

Código do produtoFRG

Comité consultivoHO

DecisãoSubstantially Equivalent

Resumo do dispositivo

Cardinal Health Sterilization Wrap is the device name listed in this FDA 510(k) record. The listed applicant is Cardinal Health200, LLC. It received FDA 510(k) clearance on 2017-04-20 under 510(k) number K161910. The device is classified under product code FRG. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Cardinal Health Sterilization Wrap?

Cardinal Health Sterilization Wrap is a medical device that received FDA 510(k) clearance on 2017-04-20. The listed applicant is Cardinal Health200, LLC. The 510(k) number is K161910.

When did Cardinal Health Sterilization Wrap receive FDA 510(k) clearance?

Cardinal Health Sterilization Wrap received FDA 510(k) clearance on 2017-04-20, under 510(k) number K161910.

Who is the listed applicant for Cardinal Health Sterilization Wrap?

The FDA 510(k) record lists Cardinal Health200, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Cardinal Health Sterilization Wrap?

The FDA product code for Cardinal Health Sterilization Wrap 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.

Fonte oficial

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