| K-number | K831784 |
| Device name | HEMOFILTRATION SYSTEM |
| Applicant | Gambro, Inc. |
| Product code | KDI |
| Device class | Class II |
| Decision date | Feb 4, 1984 |
| Decision | Substantially Equivalent |
| Regulation | 876.5860 |
AI extraction for this record is queued and will appear within 24 hours. View full FDA record →
View the full FDA submission: accessdata.fda.gov