FDA 510(k) Application Details - K122593

Device Classification Name	Electrode, Flexible Suction Coagulator   More FDA Info for this Device
510(K) Number	K122593
Device Name	Electrode, Flexible Suction Coagulator
Applicant	OPTIM LLC 64 TECHNOLOGY PARK RD STURBRIDGE, MA 01566 US Other 510(k) Applications for this Company
Contact	JEFF BARRETT Other 510(k) Applications for this Contact
Regulation Number	876.4300   More FDA Info for this Regulation Number
Classification Product Code	FEH Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	08/24/2012
Decision Date	09/13/2012
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