FDA 510(k) Application Details - K120127

Device Classification Name	Catheter, Suprapubic (And Accessories)   More FDA Info for this Device
510(K) Number	K120127
Device Name	Catheter, Suprapubic (And Accessories)
Applicant	SWAN VALLEY MEDICAL, INCORPORATED 16576 W. 53rd way Golden, CO 80403 US Other 510(k) Applications for this Company
Contact	KEVIN RANDALL Other 510(k) Applications for this Contact
Regulation Number	876.5090   More FDA Info for this Regulation Number
Classification Product Code	KOB Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	01/17/2012
Decision Date	10/26/2012
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