The following data is part of a premarket notification filed by Research Medical, Inc. with the FDA for Rmi Hemoconcentrator Preference Pack.
| Device ID | K970739 |
| 510k Number | K970739 |
| Device Name: | RMI HEMOCONCENTRATOR PREFERENCE PACK |
| Classification | Dialyzer, High Permeability With Or Without Sealed Dialysate System |
| Applicant | RESEARCH MEDICAL, INC. 6864 SOUTH 300 WEST Midvale, UT 84047 |
| Contact | R.d. Hibbert |
| Correspondent | R.d. Hibbert RESEARCH MEDICAL, INC. 6864 SOUTH 300 WEST Midvale, UT 84047 |
| Product Code | KDI |
| CFR Regulation Number | 876.5860 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-02-28 |
| Decision Date | 1997-07-08 |
| Summary: | summary |