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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 K843939
Device Name PEDIATRIC SIZE K-TUBE A OR B
Applicant
MIDWEST METABOLIC SUPPORT GROUP
6000 WEST TOUHY AVE.
CHICAGO,  IL  60648
Applicant Contact JOHN CALDERON
Correspondent
MIDWEST METABOLIC SUPPORT GROUP
6000 WEST TOUHY AVE.
CHICAGO,  IL  60648
Correspondent Contact JOHN CALDERON
Regulation Number876.5980
Classification Product Code
KNT  
Date Received10/09/1984
Decision Date 02/14/1985
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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