The following data is part of a premarket notification filed by Erika, Inc. with the FDA for Filtryzer Hollow Fiber Artif. Kidney.
| Device ID | K831175 |
| 510k Number | K831175 |
| Device Name: | FILTRYZER HOLLOW FIBER ARTIF. KIDNEY |
| Classification | Accessories, Blood Circuit, Hemodialysis |
| Applicant | ERIKA, INC. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | KOC |
| CFR Regulation Number | 876.5820 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1983-04-11 |
| Decision Date | 1984-06-22 |