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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name dislodger, stone, flexible
510(k) Number K970121
Device Name STONE DISLODGER, BASKET
Applicant
BOSTON SCIENTIFIC CORP.
ONE BOSTON SCIENTIFIC PL.
NATICK,  MA  01760 -1537
Applicant Contact CAROL J HOLLOWAY
Correspondent
BOSTON SCIENTIFIC CORP.
ONE BOSTON SCIENTIFIC PL.
NATICK,  MA  01760 -1537
Correspondent Contact CAROL J HOLLOWAY
Regulation Number876.4680
Classification Product Code
FGO  
Date Received01/14/1997
Decision Date 04/02/1997
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
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