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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Biliary Catheter For Stone Removal That May Also Allow For Irrigation And Contrast Injection
510(k) Number K011018
Device Name TAUT BALLOON CATHETER, MODEL 50640
Applicant
TAUT, INC.
2571 KANEVILLE COURT
GENEVA,  IL  60134
Applicant Contact RON KENSETH
Correspondent
TAUT, INC.
2571 KANEVILLE COURT
GENEVA,  IL  60134
Correspondent Contact RON KENSETH
Regulation Number876.5010
Classification Product Code
GCA  
Date Received04/04/2001
Decision Date 06/22/2001
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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