FDA 510(k)

HALYARD SMART-FOLD* Sterilization Wrap (H450, H650)

Número K: K181959 · 2019-03-22

Data da decisão2019-03-22

Código do produtoFRG

Comité consultivoHO

DecisãoSubstantially Equivalent

Resumo do dispositivo

HALYARD SMART-FOLD* Sterilization Wrap (H450, H650) is the device name listed in this FDA 510(k) record. The listed applicant is Owens & Minor Halyard, Inc.. It received FDA 510(k) clearance on 2019-03-22 under 510(k) number K181959. 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 HALYARD SMART-FOLD* Sterilization Wrap (H450, H650)?

HALYARD SMART-FOLD* Sterilization Wrap (H450, H650) is a medical device that received FDA 510(k) clearance on 2019-03-22. The listed applicant is Owens & Minor Halyard, Inc.. The 510(k) number is K181959.

When did HALYARD SMART-FOLD* Sterilization Wrap (H450, H650) receive FDA 510(k) clearance?

HALYARD SMART-FOLD* Sterilization Wrap (H450, H650) received FDA 510(k) clearance on 2019-03-22, under 510(k) number K181959.

Who is the listed applicant for HALYARD SMART-FOLD* Sterilization Wrap (H450, H650)?

The FDA 510(k) record lists Owens & Minor Halyard, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for HALYARD SMART-FOLD* Sterilization Wrap (H450, H650)?

The FDA product code for HALYARD SMART-FOLD* Sterilization Wrap (H450, H650) 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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