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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Duodenoscope And Accessories, Flexible/Rigid
510(k) Number K110833
Device Name CRE BALLOON DILATATION CATHETER
Applicant
Boston Scientific Corporation
100 BOSTON SCIENTIFIC WAY
MARLBOROUGH,  MA  01752
Applicant Contact JANIS TARANTO
Correspondent
Boston Scientific Corporation
100 BOSTON SCIENTIFIC WAY
MARLBOROUGH,  MA  01752
Correspondent Contact JANIS TARANTO
Regulation Number876.1500
Classification Product Code
FDT  
Subsequent Product Codes
FDF   KNQ  
Date Received03/25/2011
Decision Date 04/20/2011
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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