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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name stent, ureteral
510(k) Number K030503
Device Name MODIFICATION TO CONTOUR POLARIS URETERAL STENT
Applicant
BOSTON SCIENTIFIC CORP.
One Boston Scientific Place
natick,  MA  01760
Applicant Contact donna m gardner
Correspondent
BOSTON SCIENTIFIC CORP.
One Boston Scientific Place
natick,  MA  01760
Correspondent Contact donna m gardner
Regulation Number876.4620
Classification Product Code
FAD  
Date Received02/19/2003
Decision Date 03/17/2003
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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