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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 K861862
Device Name DIETO CONTAINER FOR ENTERAL NUTRITION
Applicant
Gil-Med Industries C/O Kegan & Kegan, Ltd.
79 W. Monroe St., Suite 1320
Chicago,  IL  60603
Applicant Contact ESTHER O KEGAN
Correspondent
Gil-Med Industries C/O Kegan & Kegan, Ltd.
79 W. Monroe St., Suite 1320
Chicago,  IL  60603
Correspondent Contact ESTHER O KEGAN
Regulation Number876.5980
Classification Product Code
KNT  
Date Received05/13/1986
Decision Date 08/11/1986
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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