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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name container, i.v.
510(k) Number K190328
Device Name HCT Empty EVA Container Pack
Applicant
Health Care Technologies
200 Butterfield Drive
Ashland,  MA  01721
Applicant Contact Adam T. Benson
Correspondent
MRC X, LLC
6075 Poplar Avenue, Suite 500
Memphis,  TN  38112
Correspondent Contact Dawn Norman
Regulation Number880.5025
Classification Product Code
KPE  
Date Received02/13/2019
Decision Date 08/15/2019
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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