FDA 510(k) Application Details - K042901

Device Classification Name	Marker,Colon   More FDA Info for this Device
510(K) Number	K042901
Device Name	Marker,Colon
Applicant	PMT CORP. 1500 PARK RD CHANHASSEN, MN 55317 US Other 510(k) Applications for this Company
Contact	JAMES R VEALE Other 510(k) Applications for this Contact
Regulation Number	000.0000   More FDA Info for this Regulation Number
Classification Product Code	NBG Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	10/20/2004
Decision Date	03/16/2005
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