FDA 510(k)

Sterisheet Sterilization Wrap

Número K: K200335 · 2020-11-12

Data da decisão2020-11-12

Código do produtoFRG

Comité consultivoHO

DecisãoSubstantially Equivalent

Resumo do dispositivo

Sterisheet Sterilization Wrap is the device name listed in this FDA 510(k) record. The listed applicant is Andersen Sterilizers, Inc.. It received FDA 510(k) clearance on 2020-11-12 under 510(k) number K200335. 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 Sterisheet Sterilization Wrap?

Sterisheet Sterilization Wrap is a medical device that received FDA 510(k) clearance on 2020-11-12. The listed applicant is Andersen Sterilizers, Inc.. The 510(k) number is K200335.

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

Sterisheet Sterilization Wrap received FDA 510(k) clearance on 2020-11-12, under 510(k) number K200335.

Who is the listed applicant for Sterisheet Sterilization Wrap?

The FDA 510(k) record lists Andersen Sterilizers, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Sterisheet Sterilization Wrap?

The FDA product code for Sterisheet 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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