FDA 510(k) Application Details - K100053

Device Classification Name	Powered Light Based Non-Laser Surgical Instrument With Thermal Effect   More FDA Info for this Device
510(K) Number	K100053
Device Name	Powered Light Based Non-Laser Surgical Instrument With Thermal Effect
Applicant	MATTIOLI ENGINEERING CORP. 8300 GREENSBORO DR. SUITE 800 MCLEAN, VA 22102 US Other 510(k) Applications for this Company
Contact	GIANFRANCO BERNABEI 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	01/08/2010
Decision Date	03/10/2010
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