The following data is part of a premarket notification filed by Hospal Medical Corp. with the FDA for Hemodialyzer, Model Rp610, Rp An 69.
| Device ID | K781464 |
| 510k Number | K781464 |
| Device Name: | HEMODIALYZER, MODEL RP610, RP AN 69 |
| Classification | Dialyzer, High Permeability With Or Without Sealed Dialysate System |
| Applicant | HOSPAL MEDICAL CORP. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | KDI |
| CFR Regulation Number | 876.5860 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1978-08-25 |
| Decision Date | 1978-12-20 |