FDA 510(k) Application Details - K060269

Device Classification Name	Choledochoscope And Accessories, Flexible/Rigid   More FDA Info for this Device
510(K) Number	K060269
Device Name	Choledochoscope And Accessories, Flexible/Rigid
Applicant	ACMI CORPORATION 136 TURNPIKE RD. SOUTHBOROUGH, MA 01772 US Other 510(k) Applications for this Company
Contact	TERRENCE E SULLIVAN Other 510(k) Applications for this Contact
Regulation Number	876.1500   More FDA Info for this Regulation Number
Classification Product Code	FBN Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	02/01/2006
Decision Date	03/31/2006
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