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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, enteral
510(k) Number K913958
Device Name FLEXIFLO QUANTUM ENTERAL NUTRITION PUMP
Applicant
ABBOTT LABORATORIES
625 CLEVELAND AVE.
COLUMBUS,  OH  43215
Applicant Contact DANIEL HAMILTON
Correspondent
ABBOTT LABORATORIES
625 CLEVELAND AVE.
COLUMBUS,  OH  43215
Correspondent Contact DANIEL HAMILTON
Regulation Number880.5725
Classification Product Code
LZH  
Date Received09/05/1991
Decision Date 02/07/1992
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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