FDA 510(k) Application Details - K100669

Device Classification Name	Electrosurgical, Cutting & Coagulation & Accessories   More FDA Info for this Device
510(K) Number	K100669
Device Name	Electrosurgical, Cutting & Coagulation & Accessories
Applicant	US MEDICAL INNOVATIONS LLC 1705 S. CAPITAL OF TEXAS HWY SUITE 500 AUSTIN, TX 78746 US Other 510(k) Applications for this Company
Contact	KRISTA OAKES 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	03/09/2010
Decision Date	04/06/2011
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	Y
Expedited Review