FDA 510(k) Application Details - K993300

Device Classification Name	Light Source, Fiberoptic, Routine   More FDA Info for this Device
510(K) Number	K993300
Device Name	Light Source, Fiberoptic, Routine
Applicant	FIBER IMAGING TECHNOLOGIES, INC. 45 PONTIAC RD. NEWTON, MA 02468 US Other 510(k) Applications for this Company
Contact	JOSEPH RESS 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	10/01/1999
Decision Date	11/05/1999
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