FDA 510(k) Application Details - K130489

Device Classification Name	Electrode, Flexible Suction Coagulator   More FDA Info for this Device
510(K) Number	K130489
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, CEO 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	02/25/2013
Decision Date	04/19/2013
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