The following data is part of a premarket notification filed by Asahi Kasei Medical Co., Ltd. with the FDA for Rexeed Series Dialyzers.
| Device ID | K051187 |
| 510k Number | K051187 |
| Device Name: | REXEED SERIES DIALYZERS |
| Classification | Dialyzer, High Permeability With Or Without Sealed Dialysate System |
| Applicant | ASAHI KASEI MEDICAL CO., LTD. 1801 ROCKVILLE PIKE, SUITE 300 Rockville, MD 20852 |
| Contact | David L West |
| Correspondent | David L West ASAHI KASEI MEDICAL CO., LTD. 1801 ROCKVILLE PIKE, SUITE 300 Rockville, MD 20852 |
| Product Code | KDI |
| CFR Regulation Number | 876.5860 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-05-09 |
| Decision Date | 2005-06-08 |
| Summary: | summary |