The following data is part of a premarket notification filed by Travenol Laboratories, S.a. with the FDA for High Efficiency Hemodialysis System.
| Device ID | K861776 |
| 510k Number | K861776 |
| Device Name: | HIGH EFFICIENCY HEMODIALYSIS SYSTEM |
| Classification | Dialyzer, High Permeability With Or Without Sealed Dialysate System |
| 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 | KDI |
| CFR Regulation Number | 876.5860 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-05-08 |
| Decision Date | 1986-06-19 |