FDA 510(k) Application Details - K013737

Device Classification Name	Catheter, Biliary, Diagnostic   More FDA Info for this Device
510(K) Number	K013737
Device Name	Catheter, Biliary, Diagnostic
Applicant	TELEMED SYSTEMS, INC. 8 KANE INDUSTRIAL DR. HUDSON, MA 01749 US Other 510(k) Applications for this Company
Contact	MICHAEL CARROLL Other 510(k) Applications for this Contact
Regulation Number	876.5010   More FDA Info for this Regulation Number
Classification Product Code	FGE Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	11/13/2001
Decision Date	03/01/2002
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	GU - Gastroenterology & Urology
Review Advisory Committee	GU - Gastroenterology & Urology
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review