510(k) K955384
DRAKE WILLOCK SYSTEM 1000 DIALYSATE DELIVERY SYSTEM W/SINGLE NEEDLE SINGLE LUMEN OPTION by
Althin Medical AB an Affiliate of Baxter Intl
— Product Code KDI
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 10, 1997
- Date Received
- November 22, 1995
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Dialyzer, High Permeability With Or Without Sealed Dialysate System
- Device Class
- Class II
- Regulation Number
- 876.5860
- Review Panel
- GU
- Submission Type