FDA 510(k) Application Details - K111165

Device Classification Name	Endoscopic Central Control Unit   More FDA Info for this Device
510(K) Number	K111165
Device Name	Endoscopic Central Control Unit
Applicant	KARL STORZ ENDOSCOPY-AMERICA, INC. 2151 E. GRAND AVE. EL SEGUNDO, CA 90245 US Other 510(k) Applications for this Company
Contact	CRYSTAL HAGAN Other 510(k) Applications for this Contact
Regulation Number	876.1500   More FDA Info for this Regulation Number
Classification Product Code	ODA Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	04/26/2011
Decision Date	01/06/2012
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	GU - Gastroenterology & Urology
Review Advisory Committee	GU - Gastroenterology & Urology
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review