FDA 510(k) Application Details - K102167

Device Classification Name	Led Light Source   More FDA Info for this Device
510(K) Number	K102167
Device Name	Led Light Source
Applicant	FIBEROPTICS TECHNOLOGY, INC. 1 QUASSETT ROAD POMFRET, CT 06258 US Other 510(k) Applications for this Company
Contact	ALLAN GUILLOTTE Other 510(k) Applications for this Contact
Regulation Number	876.1500   More FDA Info for this Regulation Number
Classification Product Code	NTN Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	08/02/2010
Decision Date	08/17/2010
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