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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 K920342
Device Name BARD STONE REMOVAL BALLOON CATHETER
Applicant
C.R. Bard, Inc.
One Park W.
Tewksbury,  MA  01876
Applicant Contact JEANETTE SCHIER
Correspondent
C.R. Bard, Inc.
One Park W.
Tewksbury,  MA  01876
Correspondent Contact JEANETTE SCHIER
Regulation Number876.5010
Classification Product Code
GCA  
Date Received01/27/1992
Decision Date 08/26/1992
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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