The following data is part of a premarket notification filed by Advocacy International, Ltd. with the FDA for Modification Asahi New Pan-series Hemofilters.
| Device ID | K855251 |
| 510k Number | K855251 |
| Device Name: | MODIFICATION ASAHI NEW PAN-SERIES HEMOFILTERS |
| Classification | Dialyzer, High Permeability With Or Without Sealed Dialysate System |
| Applicant | ADVOCACY INTERNATIONAL, LTD. INTERNATIONA SQUARE 1825 EYE STREET N.W. SUITE 400 Washington, DC 20006 |
| Contact | Richard T Ney |
| Correspondent | Richard T Ney ADVOCACY INTERNATIONAL, LTD. INTERNATIONA SQUARE 1825 EYE 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 | 1985-12-30 |
| Decision Date | 1986-02-04 |