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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 K943733
Device Name FLEXIFLO SIX ENTERAL NUTRITION 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
LZH  
Date Received08/02/1994
Decision Date 12/12/1994
Decision SE SUBJECT TO TRACKING REG (ST)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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