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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name set, administration, intravascular
510(k) Number K120548
Device Name HLIC NEEDLE-LESS VALVE
Original Applicant
HEALTH LINE INTERNATIONAL CORPORATION
803 n. 1250 w.
suite 1
centerville,  UT  84014
Original Contact nola benstog
Regulation Number880.5440
Classification Product Code
FPA  
Date Received02/23/2012
Decision Date 05/04/2012
Decision substantially equivalent (SE)
Classification Advisory Committee General Hospital
Review Advisory Committee General Hospital
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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