FDA 510(k) Application Details - K050460

Device Classification Name	Electrosurgical, Cutting & Coagulation & Accessories   More FDA Info for this Device
510(K) Number	K050460
Device Name	Electrosurgical, Cutting & Coagulation & Accessories
Applicant	GYRUS MEDICAL, INC. 6655 WEDGWOOD ROAD, SUITE 160 MAPLE GROVE, MN 55311-3602 US Other 510(k) Applications for this Company
Contact	MARK A JENSON Other 510(k) Applications for this Contact
Regulation Number	878.4400   More FDA Info for this Regulation Number
Classification Product Code	GEI Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	02/23/2005
Decision Date	10/25/2005
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	SU - General & Plastic Surgery
Review Advisory Committee	SU - General & Plastic Surgery
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review