FDA 510(k) Application Details - K112209

Device Classification Name	Accessories, Catheter, G-U   More FDA Info for this Device
510(K) Number	K112209
Device Name	Accessories, Catheter, G-U
Applicant	AVAIL MEDICAL PRODUCTS, INC. 5950 NANCY RIDGE ROAD SUITE 500 SAN DIEGO, CA 92121 US Other 510(k) Applications for this Company
Contact	STEVEN A HOWELL Other 510(k) Applications for this Contact
Regulation Number	876.5130   More FDA Info for this Regulation Number
Classification Product Code	KNY Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	08/01/2011
Decision Date	09/08/2011
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