FDA 510(k) Application Details - K131226

Device Classification Name	Light Source, Fiberoptic, Routine   More FDA Info for this Device
510(K) Number	K131226
Device Name	Light Source, Fiberoptic, Routine
Applicant	NOVAPROBE INCORPORATED 2333W. MAIN STREET SUITE 210 LANSDALE, PA 19446 US Other 510(k) Applications for this Company
Contact	MANISH INGLE Other 510(k) Applications for this Contact
Regulation Number	876.1500   More FDA Info for this Regulation Number
Classification Product Code	FCW Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	04/30/2013
Decision Date	07/24/2014
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	N
Expedited Review