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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Pump, Infusion, Pca
510(k) Number K022203
Device Name ABBOTT LIFECARE PCA 3 INFUSER, MODEL 12384
Applicant
ABBOTT LABORATORIES
DEPT 0389 BLDG J-45
200 ABBOTT PARK ROAD
ABBOTT PARK,  IL  60064 -6133
Applicant Contact FRANK POKROP
Correspondent
ABBOTT LABORATORIES
DEPT 0389 BLDG J-45
200 ABBOTT PARK ROAD
ABBOTT PARK,  IL  60064 -6133
Correspondent Contact FRANK POKROP
Regulation Number880.5725
Classification Product Code
MEA  
Date Received07/05/2002
Decision Date 08/01/2002
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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