The following data is part of a premarket notification filed by Renal Systems, Inc. with the FDA for Renaflo Hollow Fiber Dialyzer #100.1.
| Device ID | K801827 |
| 510k Number | K801827 |
| Device Name: | RENAFLO HOLLOW FIBER DIALYZER #100.1 |
| Classification | Dialyzer, Capillary, Hollow Fiber |
| Applicant | RENAL SYSTEMS, INC. 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 | 1980-07-31 |
| Decision Date | 1980-09-26 |