The following data is part of a premarket notification filed by Erika, Inc. with the FDA for Microcoil 80 Dialyzer.
| Device ID | K812811 |
| 510k Number | K812811 |
| Device Name: | MICROCOIL 80 DIALYZER |
| Classification | Dialyzer, Single Coil |
| Applicant | ERIKA, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | FHS |
| CFR Regulation Number | 876.5820 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1981-10-06 |
| Decision Date | 1981-12-03 |