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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 K033576
Device Name LIFESHIELD LATEX-FREE PRIMARY IV PUMP SET DISTAL MICROBORE PATIENT LINE, CONVERTIBLE PIN, 72 INCH, WITH 2 PRESSURE
Applicant
Abbott Laboratories
Dept. 389, Bldg. J45-2n
200 Abbott Park Rd.
Abbott Park,  IL  60064 -6133
Applicant Contact PATRICIA MELERSKI
Correspondent
Abbott Laboratories
Dept. 389, Bldg. J45-2n
200 Abbott Park Rd.
Abbott Park,  IL  60064 -6133
Correspondent Contact PATRICIA MELERSKI
Regulation Number880.5440
Classification Product Code
FPA  
Date Received11/13/2003
Decision Date 12/04/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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