The following data is part of a premarket notification filed by Minntech Corp. with the FDA for Renaflo Hdf 1350 Hemodiafilter.
| Device ID | K910236 |
| 510k Number | K910236 |
| Device Name: | RENAFLO HDF 1350 HEMODIAFILTER |
| Classification | Dialyzer, High Permeability With Or Without Sealed Dialysate System |
| Applicant | MINNTECH CORP. 14605 28TH AVE. NORTH Minneapolis, MN 55447 |
| Contact | Leroy J Fischbach |
| Correspondent | Leroy J Fischbach MINNTECH CORP. 14605 28TH AVE. NORTH Minneapolis, MN 55447 |
| Product Code | KDI |
| CFR Regulation Number | 876.5860 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-01-18 |
| Decision Date | 1991-04-09 |