FDA 510(k) Application Details - K101606

Device Classification Name	Coagulator, Laparoscopic, Unipolar (And Accessories)   More FDA Info for this Device
510(K) Number	K101606
Device Name	Coagulator, Laparoscopic, Unipolar (And Accessories)
Applicant	MCGAN TECHNOLOGY, LLC 410 RIDGE ROAD MIDDLETOWN, CT 06457 US Other 510(k) Applications for this Company
Contact	JACK GANIS Other 510(k) Applications for this Contact
Regulation Number	884.4160   More FDA Info for this Regulation Number
Classification Product Code	HFG Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	06/08/2010
Decision Date	10/01/2010
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	OB - Obstetrics/Gynecology
Review Advisory Committee	OB - Obstetrics/Gynecology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review