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510(k) K190328

HCT Empty EVA Container Pack by Health Care Technologies — Product Code KPE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 15, 2019
Date Received
February 13, 2019
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Container, I.V.
Device Class
Class II
Regulation Number
880.5025
Review Panel
HO
Submission Type

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