FDA 510(k) Application Details - K032127

Device Classification Name	Accessories, Catheter, G-U   More FDA Info for this Device
510(K) Number	K032127
Device Name	Accessories, Catheter, G-U
Applicant	HEMEDEX INCORPORATED 7 TIFFANY TRAIL HOPKINTON, MA 01748 US Other 510(k) Applications for this Company
Contact	DEBBIE IAMPIETRO 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	07/10/2003
Decision Date	12/30/2003
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