The following data is part of a premarket notification filed by Asahi Medical Co., Ltd. with the FDA for Aps Series Dialyzers (wet Models), Aps Series Dialysis (dry Models).
| Device ID | K001250 |
| 510k Number | K001250 |
| Device Name: | APS SERIES DIALYZERS (WET MODELS), APS SERIES DIALYSIS (DRY MODELS) |
| Classification | Dialyzer, High Permeability With Or Without Sealed Dialysate System |
| Applicant | ASAHI MEDICAL CO., LTD. 1801 ROCKVILLE PIKE PIKE SUITE 300 Rockville, MD 20852 |
| Contact | David L West |
| Correspondent | David L West ASAHI MEDICAL CO., LTD. 1801 ROCKVILLE PIKE PIKE SUITE 300 Rockville, MD 20852 |
| Product Code | KDI |
| CFR Regulation Number | 876.5860 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-04-19 |
| Decision Date | 2000-08-16 |