FDA 510(k) Application Details - K091968

Device Classification Name	Light Source, Fiberoptic, Routine   More FDA Info for this Device
510(K) Number	K091968
Device Name	Light Source, Fiberoptic, Routine
Applicant	KARL STORZ ENDOSCOPY-AMERICA, INC. 2151 E. GRAND AVE. EL SEGUNDO, CA 90245 US Other 510(k) Applications for this Company
Contact	CRYSTAL DIZOL 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	07/01/2009
Decision Date	09/14/2009
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