The following data is part of a premarket notification filed by Travenol Laboratories, S.a. with the FDA for Hollow Fiber Dialyzers.
| Device ID | K840845 |
| 510k Number | K840845 |
| Device Name: | HOLLOW FIBER DIALYZERS |
| Classification | Accessories, Blood Circuit, Hemodialysis |
| Applicant | TRAVENOL LABORATORIES, S.A. Deerfield , IL 60015 - |
| Contact | Julia Meyer |
| Correspondent | Julia Meyer TRAVENOL LABORATORIES, S.A. Deerfield , IL 60015 - |
| Product Code | KOC |
| CFR Regulation Number | 876.5820 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-02-24 |
| Decision Date | 1984-08-16 |