FDA 510(k) Application Details - K031527

Device Classification Name	Probe And Director, Gastro-Urology   More FDA Info for this Device
510(K) Number	K031527
Device Name	Probe And Director, Gastro-Urology
Applicant	BLUE TORCH MEDICAL TECHNOLOGIES 180 WELLS AVENUE NEWTON, MA 02459 US Other 510(k) Applications for this Company
Contact	FREDERICK TOBIA Other 510(k) Applications for this Contact
Regulation Number	876.4730   More FDA Info for this Regulation Number
Classification Product Code	FGM Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	05/15/2003
Decision Date	06/05/2003
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