FDA 510(k) Application Details - K103726

Device Classification Name	Coagulator-Cutter, Endoscopic, Unipolar (And Accessories)   More FDA Info for this Device
510(K) Number	K103726
Device Name	Coagulator-Cutter, Endoscopic, Unipolar (And Accessories)
Applicant	INTEGRA LIFESCIENCES CORPORATION 589 DAVIES DRIVE YORK, PA 17402 US Other 510(k) Applications for this Company
Contact	STEPHANIE SHEESLEY Other 510(k) Applications for this Contact
Regulation Number	884.4160   More FDA Info for this Regulation Number
Classification Product Code	KNF Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/22/2010
Decision Date	02/08/2012
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