The following data is part of a premarket notification filed by Erika, Inc. with the FDA for Dialyzer, Magniflo 100 Parallel Plate.
| Device ID | K781966 |
| 510k Number | K781966 |
| Device Name: | DIALYZER, MAGNIFLO 100 PARALLEL PLATE |
| Classification | Dialyzer, Parallel Flow |
| Applicant | ERIKA, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | FJG |
| CFR Regulation Number | 876.5820 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1978-11-24 |
| Decision Date | 1979-02-21 |