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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
Applicant
Health Line International Corporation
803 N. 1250 W.
Suite 1
Centerville,  UT  84014
Applicant Contact NOLA BENSTOG
Correspondent
Health Line International Corporation
803 N. 1250 W.
Suite 1
Centerville,  UT  84014
Correspondent Contact NOLA BENSTOG
Regulation Number880.5440
Classification Product Code
FPA  
Date Received02/23/2012
Decision Date 05/04/2012
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
Predetermined Change
Control Plan Authorized		 No
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