FDA 510(k) Application Details - K063654

Device Classification Name	Colonoscope And Accessories, Flexible/Rigid   More FDA Info for this Device
510(K) Number	K063654
Device Name	Colonoscope And Accessories, Flexible/Rigid
Applicant	KMS MEDICAL LLC 7290 SW 42ND STREET MIAMI, FL 33155 US Other 510(k) Applications for this Company
Contact	MARIO ARBESU Other 510(k) Applications for this Contact
Regulation Number	876.1500   More FDA Info for this Regulation Number
Classification Product Code	FDF Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/08/2006
Decision Date	01/31/2007
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