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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
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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