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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 K060352
Device Name HEALTH LINE INTERNATIONAL CORPORATIONS,S IV ADMINISTRATIVE SETS
Applicant
HEALTH LINE INTERNATIONAL CORPORATION
FREEPORT CENTER BLDG E-13 DR 2
PO BOX 160435
CLEARFIELD,  UT  84016 -0435
Applicant Contact JACK SPEER
Correspondent
HEALTH LINE INTERNATIONAL CORPORATION
FREEPORT CENTER BLDG E-13 DR 2
PO BOX 160435
CLEARFIELD,  UT  84016 -0435
Correspondent Contact JACK SPEER
Regulation Number880.5440
Classification Product Code
FPA  
Date Received02/13/2006
Decision Date 05/31/2006
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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