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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Tubes, Gastrointestinal (And Accessories)
510(k) Number K925102
Device Name FLEXIFLO LAPAROSCOPIC JEJUNOSTOMY KIT
Applicant
ABBOTT LABORATORIES
625 CLEVELAND AVE.
COLUMBUS,  OH  43215
Applicant Contact MICHAEL H HANEY
Correspondent
ABBOTT LABORATORIES
625 CLEVELAND AVE.
COLUMBUS,  OH  43215
Correspondent Contact MICHAEL H HANEY
Regulation Number876.5980
Classification Product Code
KNT  
Date Received10/08/1992
Decision Date 06/09/1994
Decision Substantially Equivalent - Kit (SESK)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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