FDA 510(k) Application Details - K010465

Device Classification Name	Electrosurgical, Cutting & Coagulation & Accessories   More FDA Info for this Device
510(K) Number	K010465
Device Name	Electrosurgical, Cutting & Coagulation & Accessories
Applicant	ELMED, INC. 60 WEST FAY AVE. ADDISON, IL 60101 US Other 510(k) Applications for this Company
Contact	WERNER HAUSNER 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	02/16/2001
Decision Date	05/14/2001
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	SU - General & Plastic Surgery
Review Advisory Committee	SU - General & Plastic Surgery
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review