FDA 510(k) Application Details - K103415

Device Classification Name	Powered Light Based Non-Laser Surgical Instrument   More FDA Info for this Device
510(K) Number	K103415
Device Name	Powered Light Based Non-Laser Surgical Instrument
Applicant	PHAROS LIFE CORPORATION 11-380 JAMIESON PKWY CAMBRIDGE, ONTARIO N3C 4N4 CA Other 510(k) Applications for this Company
Contact	GORDON WEHNER Other 510(k) Applications for this Contact
Regulation Number	878.4810   More FDA Info for this Regulation Number
Classification Product Code	ONE Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	11/22/2010
Decision Date	01/03/2011
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