The following data is part of a premarket notification filed by Research Medical, Inc. with the FDA for Rmi Hemoconcentrator.
Device ID | K951344 |
510k Number | K951344 |
Device Name: | RMI HEMOCONCENTRATOR |
Classification | Dialyzer, High Permeability With Or Without Sealed Dialysate System |
Applicant | RESEARCH MEDICAL, INC. 6864 SOUTH 300 WEST Midvale, UT 84047 |
Contact | Rd Hibbert |
Correspondent | Rd 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 | 1995-03-24 |
Decision Date | 1995-08-15 |