FDA 510(k) Application Details - K030503

Device Classification Name Stent, Ureteral

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510(K) Number K030503
Device Name Stent, Ureteral
Applicant BOSTON SCIENTIFIC CORP.
One Boston Scientific Place
Natick, MA 01760 US
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Contact DONNA M GARDNER
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Regulation Number 876.4620

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Classification Product Code FAD
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Date Received 02/19/2003
Decision Date 03/17/2003
Decision SESE - SUBST EQUIV
Classification Advisory Committee GU - Gastroenterology & Urology
Review Advisory Committee GU - Gastroenterology & Urology
Statement / Summary / Purged Status Summary
Type Special
Reviewed By Third Party N
Expedited Review



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