The following data is part of a premarket notification filed by Asahi Kasei Medical Co., Ltd. with the FDA for Asahi Rexeed-sx/lx Dialyzers, Models: 13sx, 15sx, 18sx, 21sx, 25sx, 13lx, 15lx, 18lx, 21lx.
| Device ID | K082515 |
| 510k Number | K082515 |
| Device Name: | ASAHI REXEED-SX/LX DIALYZERS, MODELS: 13SX, 15SX, 18SX, 21SX, 25SX, 13LX, 15LX, 18LX, 21LX |
| 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 | 2008-09-02 |
| Decision Date | 2008-10-03 |
| Summary: | summary |