The following data is part of a premarket notification filed by Guardian Chemical with the FDA for Monoxychlorosene Warexin.
| Device ID | K834455 |
| 510k Number | K834455 |
| Device Name: | MONOXYCHLOROSENE WAREXIN |
| Classification | System, Dialysate Delivery, Central Multiple Patient |
| Applicant | GUARDIAN CHEMICAL 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | FKQ |
| CFR Regulation Number | 876.5820 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1983-12-19 |
| Decision Date | 1984-07-31 |