FDA 510(k) Application Details - K962814

Device Classification Name	Shunt, Peritoneal   More FDA Info for this Device
510(K) Number	K962814
Device Name	Shunt, Peritoneal
Applicant	DENVER BIOMATERIALS, INC. 6851 HIGHWAY 73 EVERGREEN, CO 80439 US Other 510(k) Applications for this Company
Contact	LYNNE LEONARD 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	07/19/1996
Decision Date	04/14/1997
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