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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 K992494
Device Name FLEXIFLO ENTERAL FEEDING TUBE
Applicant
ROSS PRODUCT DIV. ABBOTT LABORATORIES
625 CLEVELAND AVENUE
COLUMBUS,  OH  43215
Applicant Contact DANIEL HAMILTON
Correspondent
ROSS PRODUCT DIV. ABBOTT LABORATORIES
625 CLEVELAND AVENUE
COLUMBUS,  OH  43215
Correspondent Contact DANIEL HAMILTON
Regulation Number876.5980
Classification Product Code
KNT  
Date Received07/26/1999
Decision Date 08/25/1999
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Statement Statement
Type Special
Reviewed by Third Party No
Combination Product No
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