FDA 510(k) Application Details - K041912

Device Classification Name	Endoscopic Central Control Unit   More FDA Info for this Device
510(K) Number	K041912
Device Name	Endoscopic Central Control Unit
Applicant	KARL STORZ ENDOSCOPY-AMERICA, INC. 600 CORPORATE POINTE DRIVE CULVER CITY, CA 90230-7600 US Other 510(k) Applications for this Company
Contact	SUSIE S CHEN 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	07/15/2004
Decision Date	10/25/2004
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