FDA 510(k) Application Details - K092326

Device Classification Name	Powered Light Based Non-Laser Surgical Instrument With Thermal Effect   More FDA Info for this Device
510(K) Number	K092326
Device Name	Powered Light Based Non-Laser Surgical Instrument With Thermal Effect
Applicant	JEISYS MEDICAL, INC. 5401 S. COTTONWOOD CT. GREENWOOD VILLAGE, CO 80121 US Other 510(k) Applications for this Company
Contact	Kevin Walls Other 510(k) Applications for this Contact
Regulation Number	878.4810   More FDA Info for this Regulation Number
Classification Product Code	ONF Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	08/04/2009
Decision Date	03/05/2010
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