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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name catheter, intravascular, therapeutic, short-term less than 30 days
510(k) Number K140270
Device Name NEXUS MIDLINE CT CATHETER
Applicant
HEALTH LINE INTERNATIONAL CORPORATION
PO BOX 2786
ST. GEORGE,  UT  84771 -2786
Applicant Contact JOHN E LINCOLN
Correspondent
HEALTH LINE INTERNATIONAL CORPORATION
PO BOX 2786
ST. GEORGE,  UT  84771 -2786
Correspondent Contact JOHN E LINCOLN
Regulation Number880.5200
Classification Product Code
FOZ  
Date Received02/03/2014
Decision Date 08/20/2014
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
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