The following data is part of a premarket notification filed by Renal Systems, Inc. with the FDA for Renaflo Hemoconcentrator.
Device ID | K844790 |
510k Number | K844790 |
Device Name: | RENAFLO HEMOCONCENTRATOR |
Classification | Dialyzer, High Permeability With Or Without Sealed Dialysate System |
Applicant | RENAL SYSTEMS, INC. 14905 28TH AVE. N. Minneapolis, MN 55441 |
Contact | Leroy J Fischbach |
Correspondent | Leroy J Fischbach RENAL SYSTEMS, INC. 14905 28TH AVE. N. Minneapolis, MN 55441 |
Product Code | KDI |
CFR Regulation Number | 876.5860 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1984-12-10 |
Decision Date | 1985-05-23 |