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FDA 510(k)

HCT Empty EVA Container Pack

K-Number: K190328 · 2019-08-15

Decision Date2019-08-15
Product CodeKPE
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

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

Frequently Asked Questions

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. It is manufactured by Health Care Technologies. The 510(k) number is K190328.

When was HCT Empty EVA Container Pack approved by the FDA?

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

What company makes HCT Empty EVA Container Pack?

HCT Empty EVA Container Pack is manufactured by Health Care Technologies.

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

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

Related Devices (Code: KPE)

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.