FDA 510(k) Application Details - K022447

Device Classification Name Stent, Ureteral

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510(K) Number K022447
Device Name Stent, Ureteral
Applicant C.R. BARD, INC.
8195 INDUSTRIAL BLVD.
COVINGTON, GA 30014 US
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Contact DONNA J WILSON
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Regulation Number 876.4620

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Classification Product Code FAD
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Date Received 07/26/2002
Decision Date 01/23/2003
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 Y
Expedited Review



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