FDA 510(k) Application Details - K990765

Device Classification Name Endoscopic Guidewire, Gastroenterology-Urology

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510(K) Number K990765
Device Name Endoscopic Guidewire, Gastroenterology-Urology
Applicant FLEXMEDICS
12400 WHITEWATER DR.
SUITE 2040
MINNETONKA, MN 55343 US
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Contact WILLIAM C CORRIGAN, JR.
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Regulation Number 876.1500

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Classification Product Code OCY
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Date Received 03/08/1999
Decision Date 03/15/1999
Decision SESE - SUBST EQUIV
Classification Advisory Committee GU - Gastroenterology & Urology
Review Advisory Committee GU - Gastroenterology & Urology
Statement / Summary / Purged Status Statement
Type Special
Reviewed By Third Party N
Expedited Review



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