FDA 510(k) Application Details - K113080

Device Classification Name	Coagulator-Cutter, Endoscopic, Bipolar (And Accessories)   More FDA Info for this Device
510(K) Number	K113080
Device Name	Coagulator-Cutter, Endoscopic, Bipolar (And Accessories)
Applicant	MECTRA LABS, INC. TWO QUALITY WAY BLOOMFIELD, IN 47424 US Other 510(k) Applications for this Company
Contact	CHARLES E ALLGOOD Other 510(k) Applications for this Contact
Regulation Number	884.4150   More FDA Info for this Regulation Number
Classification Product Code	HIN Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	10/18/2011
Decision Date	06/29/2012
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	OB - Obstetrics/Gynecology
Review Advisory Committee	OB - Obstetrics/Gynecology
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review