FDA 510(k) Application Details - K111315

Device Classification Name	Catheter, Biliary, Diagnostic   More FDA Info for this Device
510(K) Number	K111315
Device Name	Catheter, Biliary, Diagnostic
Applicant	NAVILYST MEDICAL, INC. 26 FOREST STREET MARLBOROUGH, MA 01752 US Other 510(k) Applications for this Company
Contact	WANDA CARPINELLA 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	05/10/2011
Decision Date	06/08/2011
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