The following data is part of a premarket notification filed by Renal Devices, Inc. with the FDA for Hollow Fiber Dialyzer Holder.
| Device ID | K802075 |
| 510k Number | K802075 |
| Device Name: | HOLLOW FIBER DIALYZER HOLDER |
| Classification | Set, Dialyzer Holder |
| Applicant | RENAL DEVICES, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | FKI |
| CFR Regulation Number | 876.5820 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1980-08-27 |
| Decision Date | 1980-09-16 |