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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 K964937
Device Name A LITHOTRIPTER-COMPATIBLE BASKET
Applicant
BOSTON SCIENTIFIC CORP.
ONE BOSTON SCIENTIFIC PL.
NATICK,  MA  01760 -1537
Applicant Contact DANIEL J DILLON
Correspondent
BOSTON SCIENTIFIC CORP.
ONE BOSTON SCIENTIFIC PL.
NATICK,  MA  01760 -1537
Correspondent Contact DANIEL J DILLON
Regulation Number876.4500
Classification Product Code
LQC  
Date Received12/10/1996
Decision Date 01/24/1997
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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