The following data is part of a premarket notification filed by Asahi Medical Co., Ltd. with the FDA for Modified Asahi Pan-series Hemofilters.
| Device ID | K914020 |
| 510k Number | K914020 |
| Device Name: | MODIFIED ASAHI PAN-SERIES HEMOFILTERS |
| Classification | Dialyzer, High Permeability With Or Without Sealed Dialysate System |
| Applicant | ASAHI MEDICAL CO., LTD. C/O ADVOCACY SERVICES GROUP 1825 I STREET, N.W., SUITE 400 Washington, DC 20006 |
| Contact | Richard T Ney |
| Correspondent | Richard T Ney ASAHI MEDICAL CO., LTD. C/O ADVOCACY SERVICES GROUP 1825 I STREET, N.W., SUITE 400 Washington, DC 20006 |
| Product Code | KDI |
| CFR Regulation Number | 876.5860 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-09-09 |
| Decision Date | 1992-03-20 |