The following data is part of a premarket notification filed by B. Braun Medizintechnologie Gmbh with the FDA for Diacap Lo Ps (10, 12, 15) And Diacap Hi Ps (10, 12, 15, 18, 20) Hemodialyzers.
| Device ID | K071518 |
| 510k Number | K071518 |
| Device Name: | DIACAP LO PS (10, 12, 15) AND DIACAP HI PS (10, 12, 15, 18, 20) HEMODIALYZERS |
| Classification | Dialyzer, High Permeability With Or Without Sealed Dialysate System |
| Applicant | B. BRAUN MEDIZINTECHNOLOGIE GMBH SCHWARZENBERGER WAY 73-79 Melsungen, DE D-34212 |
| Contact | Susan Olinger |
| Correspondent | Susan Olinger B. BRAUN MEDIZINTECHNOLOGIE GMBH SCHWARZENBERGER WAY 73-79 Melsungen, DE D-34212 |
| Product Code | KDI |
| CFR Regulation Number | 876.5860 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-06-04 |
| Decision Date | 2007-08-17 |
| Summary: | summary |