FDA 510(k)

Cardinal HealthTM Poly-Coated Open-Back Protective Gown

Número K: K182830 · 2019-04-26

Data da decisão2019-04-26

Código do produtoQPC

Comité consultivoSU

DecisãoSubstantially Equivalent

Resumo do dispositivo

Cardinal HealthTM Poly-Coated Open-Back Protective Gown is the device name listed in this FDA 510(k) record. The listed applicant is Cardinal Health200, LLC. It received FDA 510(k) clearance on 2019-04-26 under 510(k) number K182830. The device is classified under product code QPC. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Cardinal HealthTM Poly-Coated Open-Back Protective Gown?

Cardinal HealthTM Poly-Coated Open-Back Protective Gown is a medical device that received FDA 510(k) clearance on 2019-04-26. The listed applicant is Cardinal Health200, LLC. The 510(k) number is K182830.

When did Cardinal HealthTM Poly-Coated Open-Back Protective Gown receive FDA 510(k) clearance?

Cardinal HealthTM Poly-Coated Open-Back Protective Gown received FDA 510(k) clearance on 2019-04-26, under 510(k) number K182830.

Who is the listed applicant for Cardinal HealthTM Poly-Coated Open-Back Protective Gown?

The FDA 510(k) record lists Cardinal Health200, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Cardinal HealthTM Poly-Coated Open-Back Protective Gown?

The FDA product code for Cardinal HealthTM Poly-Coated Open-Back Protective Gown is QPC.

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Outros registros que listam Cardinal Health200, LLC como candidato(a)

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Dispositivos Relacionados (Código: QPC)

K262007PRIMED AAMI Level 3 Open Back GownsPRIMED Medical Products, Inc.K261115VR® Personal Protective Level 4 Gown (VR Gowns)PolyConversions, Inc.K252940VR® Personal Protective Level 3 Gown (VR Gowns)PolyConversions, Inc.K242689Gown Protetor de Nível 4 AAMIAzac Group K233526Medline Open-back Level 3 Protective GownMedline Industries, LP K230384PolyWear® Personal Protective Level 3 GownPolyConversions, Inc.

Fonte oficial

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