FDA 510(k) Application Details - K140670

Device Classification Name	Powered Light Based Non-Laser Surgical Instrument With Thermal Effect   More FDA Info for this Device
510(K) Number	K140670
Device Name	Powered Light Based Non-Laser Surgical Instrument With Thermal Effect
Applicant	ELLIPSE A/S AGERN ALLE 11 HOERSHOLM DK-2970 DK Other 510(k) Applications for this Company
Contact	OLE KOFOD 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	09/25/2014
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