FDA 510(k) Application Details - K013880

Device Classification Name	Light Source, Endoscope, Xenon Arc   More FDA Info for this Device
510(K) Number	K013880
Device Name	Light Source, Endoscope, Xenon Arc
Applicant	DESIGNS FOR VISION, INC. 760 KOEHLER AVE. RONKONKOMA, NY 11779 US Other 510(k) Applications for this Company
Contact	AMY GRUMET-AVALLONE Other 510(k) Applications for this Contact
Regulation Number	876.1500   More FDA Info for this Regulation Number
Classification Product Code	GCT Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	11/23/2001
Decision Date	12/07/2001
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	GU - Gastroenterology & Urology
Review Advisory Committee	GU - Gastroenterology & Urology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	Y
Expedited Review