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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 K844745
Device Name K-TUBE
Applicant
Midwest Metabolic Support Group
6000 W. Touhy Ave.
Chicago,  IL  60648
Applicant Contact JOHN E CALDERON
Correspondent
Midwest Metabolic Support Group
6000 W. Touhy Ave.
Chicago,  IL  60648
Correspondent Contact JOHN E CALDERON
Regulation Number876.5980
Classification Product Code
KNT  
Date Received12/06/1984
Decision Date 01/07/1985
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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