FDA 510(k) Application Details - K013784

Device Classification Name Stent, Ureteral

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510(K) Number K013784
Device Name Stent, Ureteral
Applicant BOSTON SCIENTIFIC CORP.
One Boston Scientific Place
Natick, MA 01760 US
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Contact JANET A MCGRATH
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Regulation Number 876.4620

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Classification Product Code FAD
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Date Received 11/14/2001
Decision Date 08/08/2002
Decision SESE - SUBST EQUIV
Classification Advisory Committee GU - Gastroenterology & Urology
Review Advisory Committee GU - Gastroenterology & Urology
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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