FDA 510(k)

Tyvek Sterilization Pouches with Chevron Seal

N.º K: K200336 · 2020-11-12

Fecha de decisión2020-11-12

Código de productoFRG

Comité asesorHO

DecisiónSubstantially Equivalent

Resumen del dispositivo

Tyvek Sterilization Pouches with Chevron Seal 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 K200336. 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 Tyvek Sterilization Pouches with Chevron Seal?

Tyvek Sterilization Pouches with Chevron Seal 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 K200336.

When did Tyvek Sterilization Pouches with Chevron Seal receive FDA 510(k) clearance?

Tyvek Sterilization Pouches with Chevron Seal received FDA 510(k) clearance on 2020-11-12, under 510(k) number K200336.

Who is the listed applicant for Tyvek Sterilization Pouches with Chevron Seal?

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 Tyvek Sterilization Pouches with Chevron Seal?

The FDA product code for Tyvek Sterilization Pouches with Chevron Seal is FRG.

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Otros registros que enlistan a Andersen Sterilizers, Inc. como solicitante

K213296Anprolene SteriTest RRBI K202879EOGas 4 Endo-SteriTest RRBI K200334Dosímetro AN1036 K192978EOGas 4 Ethylene Oxide Gas Sterilizer K200335Sterisheet Sterilization Wrap K192980EOGas 4 Endo-SteriTest

Ver todos los 13 dispositivos →

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

Ver en la base de datos de la FDA →

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