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FDA 510(k) Application Details - K091355
Device Classification Name
Snare, Flexible
More FDA Info for this Device
510(K) Number
K091355
Device Name
Snare, Flexible
Applicant
CONMED ENDOSCOPIC TECHNOLOGIES, INC.
ONE EXECUTIVE DRIVE
SUITE 101
CHELMSFORD, MA 01824 US
Other 510(k) Applications for this Company
Contact
KAREN PROVENCHER
Other 510(k) Applications for this Contact
Regulation Number
876.4300
More FDA Info for this Regulation Number
Classification Product Code
FDI
Other 510(k) Applications for this Device
More FDA Info for this Product Code
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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