The following data is part of a premarket notification filed by Asahi Medical Co., Ltd. with the FDA for High Flux Hemodialysis Membrane Dialyzer Or High Flux Hollow Fiber Dialyzer, Models Aps-r, -m, -s, -e, And -ex.
| Device ID | K041726 |
| 510k Number | K041726 |
| Device Name: | HIGH FLUX HEMODIALYSIS MEMBRANE DIALYZER OR HIGH FLUX HOLLOW FIBER DIALYZER, MODELS APS-R, -M, -S, -E, AND -EX |
| 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 | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-06-25 |
| Decision Date | 2004-07-23 |
| Summary: | summary |