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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 K852966
Device Name ENTERAL FEEDING CONTAINER
Applicant
EMPIRE INDUSTRIES, INC.
262 BROADWAY,P.O. BOX 1045
NORTH ATTLEBORO,  MA  02761
Applicant Contact ROLAND FERLAND
Correspondent
EMPIRE INDUSTRIES, INC.
262 BROADWAY,P.O. BOX 1045
NORTH ATTLEBORO,  MA  02761
Correspondent Contact ROLAND FERLAND
Regulation Number876.5980
Classification Product Code
KNT  
Date Received07/12/1985
Decision Date 08/27/1985
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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