510(k) K071518
DIACAP LO PS (10, 12, 15) AND DIACAP HI PS (10, 12, 15, 18, 20) HEMODIALYZERS by
B. Braun Medizintechnologie GmbH
— Product Code KDI
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 17, 2007
- Date Received
- June 4, 2007
- 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