The following data is part of a premarket notification filed by Csam, Inc. with the FDA for Ckhemo, Model Ckhemo Version 1.0.
| Device ID | K992255 |
| 510k Number | K992255 |
| Device Name: | CKHEMO, MODEL CKHEMO VERSION 1.0 |
| Classification | System, Dialysate Delivery, Single Patient |
| Applicant | CSAM, INC. 1890 14TH ST. Bettendorf, IA 52722 |
| Contact | Yoobong Kim |
| Correspondent | Yoobong Kim CSAM, INC. 1890 14TH ST. Bettendorf, IA 52722 |
| Product Code | FKP |
| CFR Regulation Number | 876.5820 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-07-06 |
| Decision Date | 1999-11-30 |