FDA 510(k) Application Details - K993951

Device Classification Name	Marker,Colon   More FDA Info for this Device
510(K) Number	K993951
Device Name	Marker,Colon
Applicant	CHEK-MED SYSTEMS 11 PHELPS WAY P.O. BOX 289 WILLINGTON, CT 06279 US Other 510(k) Applications for this Company
Contact	ROB WHALEN 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	11/22/1999
Decision Date	02/18/2000
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	GU - Gastroenterology & Urology
Review Advisory Committee	GU - Gastroenterology & Urology
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review