FDA 510(k) Application Details - K041732

Device Classification Name	Probe And Director, Gastro-Urology   More FDA Info for this Device
510(K) Number	K041732
Device Name	Probe And Director, Gastro-Urology
Applicant	BLUE TORCH MEDICAL TECHNOLOGIES 200 HOMER AVE ASHLAND TECH. CENTER ASHLAND, MA 01721 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	06/25/2004
Decision Date	09/21/2004
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