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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 K030002
Device Name LIFESHIELD PRIMARY IV SET CONV. PIN. CLAVE; LF LC 5000 PLUMSET-DUAL W/CONV PIN & CAP PORT; LIFESHIELD LF MACROBORE EXT.
Applicant
ABBOTT LABORATORIES
D-389, BLDG. J45-2
200 ABBOTT PARK ROAD
ABBOTT PARK,  IL  60064 -6157
Applicant Contact NOCOHL R WILDING
Correspondent
ABBOTT LABORATORIES
D-389, BLDG. J45-2
200 ABBOTT PARK ROAD
ABBOTT PARK,  IL  60064 -6157
Correspondent Contact NOCOHL R WILDING
Regulation Number880.5440
Classification Product Code
FPA  
Date Received01/02/2003
Decision Date 01/27/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Statement Statement
Type Special
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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