510(k) K091978
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 25, 2010
- Date Received
- July 1, 2009
- 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