FDA 510(k) Application Details - K091355

Device Classification Name Snare, Flexible

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510(K) Number K091355
Device Name Snare, Flexible
Applicant CONMED ENDOSCOPIC TECHNOLOGIES, INC.
ONE EXECUTIVE DRIVE
SUITE 101
CHELMSFORD, MA 01824 US
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Contact KAREN PROVENCHER
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Regulation Number 876.4300

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Classification Product Code FDI
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Date Received 05/08/2009
Decision Date 07/22/2009
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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