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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Lithotriptor, Biliary Mechanical
510(k) Number K040447
Device Name TRAPEZOID RX LITHOTRIPTER COMPATIBLE BASKET, MODELS 1086, 1087, 1088
Applicant
Boston Scientific Corp
One Boston Scientific Pl.
Natick,  MA  01760 -1537
Applicant Contact JAMES D MCMAHON
Correspondent
Boston Scientific Corp
One Boston Scientific Pl.
Natick,  MA  01760 -1537
Correspondent Contact JAMES D MCMAHON
Regulation Number876.4500
Classification Product Code
LQC  
Date Received02/20/2004
Decision Date 03/12/2004
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
Predetermined Change
Control Plan Authorized		 No
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