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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 K952799
Device Name ABBOTT XL3M INFUSION PUMP
Applicant
Abbott Laboratories
One Abbott Park Rd.
D389, Ap30
Abbott Park,  IL  60064
Applicant Contact DAVID T GUZEK
Correspondent
Abbott Laboratories
One Abbott Park Rd.
D389, Ap30
Abbott Park,  IL  60064
Correspondent Contact DAVID T GUZEK
Regulation Number880.5725
Classification Product Code
FRN  
Date Received06/19/1995
Decision Date 01/18/1996
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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