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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 K843392
Device Name GAUDERER GASTROSTOMY BUTTON
Applicant
American V. Mueller
6600 W. Touhy
Chicago,  IL  60648
Applicant Contact MATTHEW NOWLAND
Correspondent
American V. Mueller
6600 W. Touhy
Chicago,  IL  60648
Correspondent Contact MATTHEW NOWLAND
Regulation Number876.5980
Classification Product Code
KNT  
Date Received08/29/1984
Decision Date 10/11/1984
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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