FDA 510(k) Application Details - K163185

Device Classification Name	Illuminator, Fiberoptic, Surgical Field   More FDA Info for this Device
510(K) Number	K163185
Device Name	Illuminator, Fiberoptic, Surgical Field
Applicant	ISOLUX LLC 1045 COLLIER CENTER WAY SUITE #6 NAPLES, FL 34110 US Other 510(k) Applications for this Company
Contact	NIKOLAOS ANDREOULAKIS Other 510(k) Applications for this Contact
Regulation Number	878.4580   More FDA Info for this Regulation Number
Classification Product Code	HBI Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	11/14/2016
Decision Date	11/21/2016
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	SU - General & Plastic Surgery
Review Advisory Committee	SU - General & Plastic Surgery
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	Y
Expedited Review