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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Tube, Nasogastric
510(k) Number K791531
Device Name FLEXIFLO ENTERAL PUMP SET
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
BSS  
Date Received08/10/1979
Decision Date 09/12/1979
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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