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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name tube, feeding
510(k) Number K912972
Device Name FLEXIFLO OVER THE GUIDEWIRE JEJUNAL FEEDING TUBE
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 Number876.5980
Classification Product Code
FPD  
Date Received07/08/1991
Decision Date 09/23/1991
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
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