FDA 510(k) Application Details - K022026

Device Classification Name Catheter, Biliary, Diagnostic

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510(K) Number K022026
Device Name Catheter, Biliary, Diagnostic
Applicant MEDTRONIC AVE, INC.
2170-A NORTHPOINT PRKWY
SANTA ROSA, CA 95407 US
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Contact KEVIN DRISKO
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Regulation Number 876.5010

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Classification Product Code FGE
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Date Received 06/21/2002
Decision Date 07/19/2002
Decision SESU - SE - WITH LIMITATIONS
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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