The following data is part of a premarket notification filed by Asahi Medical Co., Ltd. with the FDA for Modified Am-series Dialyzers.
| Device ID | K854575 |
| 510k Number | K854575 |
| Device Name: | MODIFIED AM-SERIES DIALYZERS |
| Classification | Dialyzer, Capillary, Hollow Fiber |
| Applicant | ASAHI MEDICAL CO., LTD. INT'L SQUARE 1825 EYE STREET NW #400 Washington, DC 2006 |
| Contact | Richard T Ney |
| Correspondent | Richard T Ney ASAHI MEDICAL CO., LTD. INT'L SQUARE 1825 EYE STREET NW #400 Washington, DC 2006 |
| Product Code | FJI |
| CFR Regulation Number | 876.5820 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-11-06 |
| Decision Date | 1985-12-02 |