The following data is part of a premarket notification filed by Minntech Corp. with the FDA for Renaflo Ii Hf 2000 Hemofilter.
| Device ID | K000028 |
| 510k Number | K000028 |
| Device Name: | RENAFLO II HF 2000 HEMOFILTER |
| Classification | Dialyzer, High Permeability With Or Without Sealed Dialysate System |
| Applicant | MINNTECH CORP. 14905 28TH AVE. N. Minneapolis, MN 55447 |
| Contact | Richard M Ormsbee |
| Correspondent | Richard M Ormsbee MINNTECH CORP. 14905 28TH AVE. N. 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 | 2000-01-05 |
| Decision Date | 2000-04-04 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20860113000656 | K000028 | 000 |