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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 ROAD
ABBOTT PARK,  IL  60064 -6133
Applicant Contact PATRICIA MELERSKI
Correspondent
ABBOTT LABORATORIES
DEPT. 389, BLDG. J45-2N
200 ABBOTT PARK ROAD
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
Recalls CDRH Recalls
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