FDA 510(k) Application Details - K961039

Device Classification Name	Dialyzer, Capillary, Hollow Fiber   More FDA Info for this Device
510(K) Number	K961039
Device Name	Dialyzer, Capillary, Hollow Fiber
Applicant	DAYSPRING MEDICAL, INC. 1936 BEACON CT. BOULDER, CO 80302 US Other 510(k) Applications for this Company
Contact	NEIL RASMUSSEN Other 510(k) Applications for this Contact
Regulation Number	876.5820   More FDA Info for this Regulation Number
Classification Product Code	FJI Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	03/14/1996
Decision Date	09/12/1996
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	GU - Gastroenterology & Urology
Review Advisory Committee	GU - Gastroenterology & Urology
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review