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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 K944669
Device Name FLEXIFLO QUANTUM ENTERAL PUMP
Applicant
ABBOTT MFG., INC.
1033 KINGSMILL PKWY.
COLUMBUS,  OH  43229
Applicant Contact MICHAEL H HANEY
Correspondent
ABBOTT MFG., INC.
1033 KINGSMILL PKWY.
COLUMBUS,  OH  43229
Correspondent Contact MICHAEL H HANEY
Regulation Number880.5725
Classification Product Code
FRN  
Subsequent Product Code
LZH  
Date Received09/13/1994
Decision Date 07/24/1995
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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