Organon Teknika Corp. · Class II · Cleared Dec 16, 1985
| K-number | K854367 |
| Device name | HD-SECURA HEMADIALYSIS MACHINE |
| Applicant | Organon Teknika Corp. |
| Product code | FKP |
| Device class | Class II |
| Decision date | Dec 16, 1985 |
| Decision | Substantially Equivalent |
| Regulation | 876.5820 |
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