FDA 510(k) Application Details - K141330

Device Classification Name	Light, Surgical, Fiberoptic   More FDA Info for this Device
510(K) Number	K141330
Device Name	Light, Surgical, Fiberoptic
Applicant	ENROXTECH, INC. 4655 KIRKWOOD COURT BOULDER, CO 80301 US Other 510(k) Applications for this Company
Contact	LEWIS WARD Other 510(k) Applications for this Contact
Regulation Number	878.4580   More FDA Info for this Regulation Number
Classification Product Code	FST Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	05/21/2014
Decision Date	12/15/2014
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