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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 K841784
Device Name FLEXIFLO-III PORTABLE ENTERAL NUTRI
Applicant
ABBOTT LABORATORIES
803 N. Front St. Suite 3
McHenry,  IL  60050
Correspondent
ABBOTT LABORATORIES
803 N. Front St. Suite 3
McHenry,  IL  60050
Regulation Number880.5725
Classification Product Code
FRN  
Date Received04/30/1984
Decision Date 06/07/1984
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
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