The following data is part of a premarket notification filed by Erika, Inc. with the FDA for Toray Industries Filtryzer Hollow Fiber Kidney B1l.
| Device ID | K850866 |
| 510k Number | K850866 |
| Device Name: | TORAY INDUSTRIES FILTRYZER HOLLOW FIBER KIDNEY B1L |
| Classification | Dialyzer, High Permeability With Or Without Sealed Dialysate System |
| 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 | KDI |
| CFR Regulation Number | 876.5860 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-03-01 |
| Decision Date | 1985-04-03 |