FDA 510(k) Application Details - K003451

Device Classification Name	Shunt, Peritoneal   More FDA Info for this Device
510(K) Number	K003451
Device Name	Shunt, Peritoneal
Applicant	DENVER BIOMEDICALS, INC. 14998 W. 6TH AVE., BLDG. E700 GOLDEN, CO 80401 US Other 510(k) Applications for this Company
Contact	BONNIE VIVIAN Other 510(k) Applications for this Contact
Regulation Number	876.5955   More FDA Info for this Regulation Number
Classification Product Code	KPM Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	11/07/2000
Decision Date	01/02/2001
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