FDA 510(k)

Tyvek Sterilization Pouches with Chevron Seal

Número K: K200336 · 2020-11-12

Data da decisão2020-11-12

Código do produtoFRG

Comité consultivoHO

DecisãoSubstantially Equivalent

Resumo do 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.

Perguntas frequentes

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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Outros registros que listam Andersen Sterilizers, Inc. como candidato(a)

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Dispositivos Relacionados (Código: FRG)

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Fonte oficial

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