FDA 510(k)

Reliance® Fusion Sterilização

Número K: K230137 · 2023-12-07

RequerenteAhlstrom-Munksjo Nonwovens, LLC

Data da decisão2023-12-07

Código do produtoFRG

Comité consultivoHO

DecisãoSubstantially Equivalent

Resumo do 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.

Perguntas frequentes

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)

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Fonte oficial

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