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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
Recalls CDRH Recalls
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