FDA 510(k)

Reliance® Fundas de Estilización de Fusion

N.º K: K230137 · 2023-12-07

SolicitanteAhlstrom-Munksjo Nonwovens, LLC

Fecha de decisión2023-12-07

Código de productoFRG

Comité asesorHO

DecisiónSubstantially Equivalent

Resumen del dispositivo

Reliance® Fusion Sterilization Wraps is the device name listed in this FDA 510(k) record. The listed applicant is Ahlstrom-Munksjo Nonwovens, LLC. It received FDA 510(k) clearance on 2023-12-07 under 510(k) number K230137. 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 Reliance® Fusion Sterilization Wraps?

Reliance® Fusion Sterilization Wraps is a medical device that received FDA 510(k) clearance on 2023-12-07. The listed applicant is Ahlstrom-Munksjo Nonwovens, LLC. The 510(k) number is K230137.

When did Reliance® Fusion Sterilization Wraps receive FDA 510(k) clearance?

Reliance® Fusion Sterilization Wraps received FDA 510(k) clearance on 2023-12-07, under 510(k) number K230137.

Who is the listed applicant for Reliance® Fusion Sterilization Wraps?

The FDA 510(k) record lists Ahlstrom-Munksjo Nonwovens, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Reliance® Fusion Sterilization Wraps?

The FDA product code for Reliance® Fusion Sterilization Wraps 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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