The following data is part of a premarket notification filed by Advocacy International, Ltd. with the FDA for Asahi Am Series Dialyzers.
| Device ID | K855212 |
| 510k Number | K855212 |
| Device Name: | ASAHI AM SERIES DIALYZERS |
| Classification | Dialyzer, Capillary, Hollow Fiber |
| 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 | FJI |
| CFR Regulation Number | 876.5820 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-12-30 |
| Decision Date | 1986-01-21 |