FDA 510(k) Application Details - K122605

Device Classification Name	Coagulator-Cutter, Endoscopic, Bipolar (And Accessories)   More FDA Info for this Device
510(K) Number	K122605
Device Name	Coagulator-Cutter, Endoscopic, Bipolar (And Accessories)
Applicant	GYRUS ACMI, INC. 136 TURNPIKE RD. SOUTHBOROUGH, MA 01772 US Other 510(k) Applications for this Company
Contact	NEIL KELLY 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	08/27/2012
Decision Date	12/05/2012
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	OB - Obstetrics/Gynecology
Review Advisory Committee	OB - Obstetrics/Gynecology
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review