The following data is part of a premarket notification filed by Erika, Inc. with the FDA for Toray Indus. Filtryzer Hollow Fiber Artificial Kid.
| Device ID | K850654 |
| 510k Number | K850654 |
| Device Name: | TORAY INDUS. FILTRYZER HOLLOW FIBER ARTIFICIAL KID |
| Classification | Dialyzer, Capillary, Hollow Fiber |
| Applicant | ERIKA, INC. ONE ERIKA PLAZA Rockleigh, NJ 07647 |
| Contact | Del Donna |
| Correspondent | Del Donna ERIKA, INC. ONE ERIKA PLAZA Rockleigh, NJ 07647 |
| Product Code | FJI |
| CFR Regulation Number | 876.5820 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-02-19 |
| Decision Date | 1985-03-07 |