FDA 510(k)

HCT Empty EVA Container Pack

Número K: K190328 · 2019-08-15

Data da decisão2019-08-15

Código do produtoKPE

Comité consultivoHO

DecisãoSubstantially Equivalent

Resumo do dispositivo

HCT Empty EVA Container Pack is the device name listed in this FDA 510(k) record. The listed applicant is Health Care Technologies. It received FDA 510(k) clearance on 2019-08-15 under 510(k) number K190328. The device is classified under product code KPE. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the HCT Empty EVA Container Pack?

HCT Empty EVA Container Pack is a medical device that received FDA 510(k) clearance on 2019-08-15. The listed applicant is Health Care Technologies. The 510(k) number is K190328.

When did HCT Empty EVA Container Pack receive FDA 510(k) clearance?

HCT Empty EVA Container Pack received FDA 510(k) clearance on 2019-08-15, under 510(k) number K190328.

Who is the listed applicant for HCT Empty EVA Container Pack?

The FDA 510(k) record lists Health Care Technologies as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for HCT Empty EVA Container Pack?

The FDA product code for HCT Empty EVA Container Pack is KPE.

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