The following data is part of a premarket notification filed by Medisystems Corp. with the FDA for Kf-e Series Of Hollow Fiber Dialyzers.
| Device ID | K812353 |
| 510k Number | K812353 |
| Device Name: | KF-E SERIES OF HOLLOW FIBER DIALYZERS |
| Classification | Dialyzer, Capillary, Hollow Fiber |
| Applicant | MEDISYSTEMS CORP. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | FJI |
| CFR Regulation Number | 876.5820 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1981-08-19 |
| Decision Date | 1981-09-16 |