FDA 510(k) Application Details - K060023

Device Classification Name Catheter, Biliary, Diagnostic

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510(K) Number K060023
Device Name Catheter, Biliary, Diagnostic
Applicant ANGIODYNAMICS, INC.
603 QUEENSBURY AVE.
QUEENSBURY, NY 12804 US
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Contact TERI JUCKETT
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Regulation Number 876.5010

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Classification Product Code FGE
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Date Received 01/04/2006
Decision Date 03/09/2006
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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