The following data is part of a premarket notification filed by Travenol Laboratories, S.a. with the FDA for St Family Of Hollow Fiber Dialyzers.
| Device ID | K844756 |
| 510k Number | K844756 |
| Device Name: | ST FAMILY OF HOLLOW FIBER DIALYZERS |
| Classification | System, Dialysate Delivery, Central Multiple Patient |
| Applicant | TRAVENOL LABORATORIES, S.A. Deerfield, IL 60015 |
| Contact | Julia A Meyer |
| Correspondent | Julia A Meyer TRAVENOL LABORATORIES, S.A. Deerfield, IL 60015 |
| Product Code | FKQ |
| CFR Regulation Number | 876.5820 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-12-05 |
| Decision Date | 1985-01-16 |