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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Bougie, Esophageal, And Gastrointestinal, Gastro-Urology
510(k) Number K972119
Device Name MALONEY BOUGE (1210-XX)/HURST BOUGIE (1212-XX)
Applicant
Medovations, Inc.
W194 N11340 Mccormick Dr.
Germantown,  WI  53022
Applicant Contact CHARLES G STANFORD
Correspondent
Medovations, Inc.
W194 N11340 Mccormick Dr.
Germantown,  WI  53022
Correspondent Contact CHARLES G STANFORD
Regulation Number876.5365
Classification Product Code
FAT  
Date Received06/05/1997
Decision Date 02/02/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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