FDA 510(k) Application Details - K081477

Device Classification Name	Light Source, Fiberoptic, Routine   More FDA Info for this Device
510(K) Number	K081477
Device Name	Light Source, Fiberoptic, Routine
Applicant	INTEGRA LUXTEC, INC. 99 HARTWELL ST. WEST BOYLSTON, MA 01583 US Other 510(k) Applications for this Company
Contact	RITA WADLEIGH 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	05/27/2008
Decision Date	06/18/2008
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	GU - Gastroenterology & Urology
Review Advisory Committee	GU - Gastroenterology & Urology
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review