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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 K113622
Device Name ORION II CT CVC
Applicant
HEALTH LINE INTERNATIONAL CORPORATION (HLIC)
803 North 1250 West
Suite 1
Centerville,  UT  84014
Applicant Contact NOLA BENSTOG
Correspondent
HEALTH LINE INTERNATIONAL CORPORATION (HLIC)
803 North 1250 West
Suite 1
Centerville,  UT  84014
Correspondent Contact NOLA BENSTOG
Regulation Number880.5200
Classification Product Code
FOZ  
Date Received12/08/2011
Decision Date 05/18/2012
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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