FDA 510(k) Application Details - K082925

Device Classification Name	Light Source, Endoscope, Xenon Arc   More FDA Info for this Device
510(K) Number	K082925
Device Name	Light Source, Endoscope, Xenon Arc
Applicant	KARL STORZ ENDOSCOPY-AMERICA, INC. 600 CORPORATE POINTE DRIVE CULVER CITY, CA 90230 US Other 510(k) Applications for this Company
Contact	MONIKA CAMPBELL 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	10/01/2008
Decision Date	12/18/2008
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