FDA 510(k) Application Details - K140668

Device Classification Name	Powered Light Based Non-Laser Surgical Instrument With Thermal Effect   More FDA Info for this Device
510(K) Number	K140668
Device Name	Powered Light Based Non-Laser Surgical Instrument With Thermal Effect
Applicant	GLOBAL MEDICAL TECHNOLOGY S.L. C/ Isla de Alegranza 2 Nave 51 San Sebastian de los Reyes 28703 ES Other 510(k) Applications for this Company
Contact	Derliz David Diaz Sanchez 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	03/18/2014
Decision Date	12/19/2014
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