FDA 510(k) Application Details - K031758

Device Classification Name	Telescope, Rigid, Endoscopic   More FDA Info for this Device
510(K) Number	K031758
Device Name	Telescope, Rigid, Endoscopic
Applicant	ACMI CORPORATION 136 TURNPIKE RD. SOUTHBOROUGH, MA 01772-2104 US Other 510(k) Applications for this Company
Contact	GABRIEL J MURACA Other 510(k) Applications for this Contact
Regulation Number	876.1500   More FDA Info for this Regulation Number
Classification Product Code	FBP Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	06/06/2003
Decision Date	09/02/2003
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