FDA 510(k) Application Details - K132135

Device Classification Name	Coagulator-Cutter, Endoscopic, Unipolar (And Accessories)   More FDA Info for this Device
510(K) Number	K132135
Device Name	Coagulator-Cutter, Endoscopic, Unipolar (And Accessories)
Applicant	LINA MEDICAL APS 386 WEST MAIN ST. SUITE 7 NORTHBOROUGH, MA 01532 US Other 510(k) Applications for this Company
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	07/10/2013
Decision Date	01/31/2014
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