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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 Rd.
Abbott Park,  IL  60064 -6157
Applicant Contact NOCOHL R WILDING
Correspondent
Abbott Laboratories
D-389, Bldg. J45-2
200 Abbott Park Rd.
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
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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