510(k) K082515
ASAHI REXEED-SX/LX DIALYZERS, MODELS: 13SX, 15SX, 18SX, 21SX, 25SX, 13LX, 15LX, 18LX, 21LX by
Asahi Kasei Medical Co., Ltd.
— Product Code KDI
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 3, 2008
- Date Received
- September 2, 2008
- Clearance Type
- Special
- 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