The following data is part of a premarket notification filed by Minntech Corp. with the FDA for High Permeability Dialyer.
| Device ID | K923312 |
| 510k Number | K923312 |
| Device Name: | HIGH PERMEABILITY DIALYER |
| 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 | 1992-07-07 |
| Decision Date | 1994-02-18 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 30677964059149 | K923312 | 000 |
| 30677964000080 | K923312 | 000 |
| 30677964000073 | K923312 | 000 |
| 30677964000066 | K923312 | 000 |