The following data is part of a premarket notification filed by Surgikos, Inc. with the FDA for Cidex*dialyzer Disinfecting Solution.
| Device ID | K822535 |
| 510k Number | K822535 |
| Device Name: | CIDEX*DIALYZER DISINFECTING SOLUTION |
| Classification | System, Dialysate Delivery, Central Multiple Patient |
| Applicant | SURGIKOS, INC. TX |
| Product Code | FKQ |
| CFR Regulation Number | 876.5820 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1982-08-24 |
| Decision Date | 1982-09-30 |