FDA 510(k) Application Details - K013921

Device Classification Name Stent, Ureteral

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510(K) Number K013921
Device Name Stent, Ureteral
Applicant PORGES S.A.
CENTRE D'AFFAIRES
LA BOURSIDIERE
LE PLESSIS ROBINSON CEDEX 92357 FR
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Contact BERNARD ISMAEL
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Regulation Number 876.4620

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Classification Product Code FAD
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Date Received 11/27/2001
Decision Date 10/17/2002
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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