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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 K010002
Device Name CONTOUR POLARIS URETERAL STENT
Applicant
Boston Scientific Corp
One Boston Scientific Place
Natick,  MA  01760
Applicant Contact LINDA J VARROSO
Correspondent
Boston Scientific Corp
One Boston Scientific Place
Natick,  MA  01760
Correspondent Contact LINDA J VARROSO
Regulation Number876.4620
Classification Product Code
FAD  
Date Received01/02/2001
Decision Date 01/22/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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