FDA 510(k) Application Details - K033368

Device Classification Name	Catheter, Ureteral, Gastro-Urology   More FDA Info for this Device
510(K) Number	K033368
Device Name	Catheter, Ureteral, Gastro-Urology
Applicant	FOSSA MEDICAL, INC. 580 HARRISON AVE., 4TH FL. BOSTON, MA 02118 US Other 510(k) Applications for this Company
Contact	GLORIA KOLB Other 510(k) Applications for this Contact
Regulation Number	876.5130   More FDA Info for this Regulation Number
Classification Product Code	EYB Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	10/21/2003
Decision Date	11/26/2003
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