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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
510(k) Number K011096
Device Name ABBOTT ACCLAIM ENCORE, MODEL 12237
Applicant
Abbott Laboratories
200 Abbott Park Rd.
Abbott Park,  IL  60064
Applicant Contact FRANK POKROP
Correspondent
Abbott Laboratories
200 Abbott Park Rd.
Abbott Park,  IL  60064
Correspondent Contact FRANK POKROP
Regulation Number880.5725
Classification Product Code
FRN  
Date Received04/10/2001
Decision Date 05/01/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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