The following data is part of a premarket notification filed by Organon Teknika Corp. with the FDA for Hd-secura Hemadialysis Machine.
| Device ID | K854367 |
| 510k Number | K854367 |
| Device Name: | HD-SECURA HEMADIALYSIS MACHINE |
| Classification | System, Dialysate Delivery, Single Patient |
| Applicant | ORGANON TEKNIKA CORP. 5300 SOUTH PORTLAND AVE. Oklahoma City, OK 73119 |
| Contact | Martin Roberts |
| Correspondent | Martin Roberts ORGANON TEKNIKA CORP. 5300 SOUTH PORTLAND AVE. Oklahoma City, OK 73119 |
| Product Code | FKP |
| CFR Regulation Number | 876.5820 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-10-29 |
| Decision Date | 1985-12-16 |