The following data is part of a premarket notification filed by Minntech Corp. with the FDA for Minntech Minnifilter Plus Hemofilter And Tubing Set.
| Device ID | K962707 |
| 510k Number | K962707 |
| Device Name: | MINNTECH MINNIFILTER PLUS HEMOFILTER AND TUBING SET |
| Classification | Dialyzer, High Permeability With Or Without Sealed Dialysate System |
| Applicant | MINNTECH CORP. 14605 28TH AVE. NORTH Minneapolis, MN 55447 |
| Contact | Leroy Fischbach |
| Correspondent | Leroy 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 | 1996-07-12 |
| Decision Date | 1996-10-09 |