FDA 510(k) Application Details - K992564

Device Classification Name	Dialyzer, High Permeability With Or Without Sealed Dialysate System   More FDA Info for this Device
510(K) Number	K992564
Device Name	Dialyzer, High Permeability With Or Without Sealed Dialysate System
Applicant	ALTHIN MEDICAL AB FRIDHEMSVAGEN 15 RONNEBY S-37221 SE Other 510(k) Applications for this Company
Contact	LARS-OLOF SANDBERG Other 510(k) Applications for this Contact
Regulation Number	876.5860   More FDA Info for this Regulation Number
Classification Product Code	KDI Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	08/02/1999
Decision Date	01/18/2000
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