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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 K810996
Device Name ENTERNAL PUMP SET W/INTEGRAL CONTAINER
Applicant
Abbott Laboratories
One Abbott Park Rd.
Abbott Park,  IL  60064
Correspondent
Abbott Laboratories
One Abbott Park Rd.
Abbott Park,  IL  60064
Regulation Number876.5980
Classification Product Code
KNT  
Date Received04/14/1981
Decision Date 04/29/1981
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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