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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 K063118
Device Name BARD BALLOON DILATION KIT WITH TRIFUNNEL GASTROSTOMY TUBE
Applicant
C.R Bard, Inc.
5425 W. Amelia Earhart Dr.
Salt Lake City,  UT  84116
Applicant Contact SUSAN SCOTT
Correspondent
C.R Bard, Inc.
5425 W. Amelia Earhart Dr.
Salt Lake City,  UT  84116
Correspondent Contact SUSAN SCOTT
Regulation Number876.5980
Classification Product Code
KNT  
Date Received10/11/2006
Decision Date 02/13/2007
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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