The following data is part of a premarket notification filed by Minntech Corp. with the FDA for Renaguard Dialysate Filter.
| Device ID | K945136 |
| 510k Number | K945136 |
| Device Name: | RENAGUARD DIALYSATE FILTER |
| Classification | Subsystem, Water Purification |
| Applicant | MINNTECH CORP. 14905 28TH AVE. N. Minneapolis, MN 55447 |
| Contact | Leroy J Fischbach |
| Correspondent | Leroy J Fischbach MINNTECH CORP. 14905 28TH AVE. N. Minneapolis, MN 55447 |
| Product Code | FIP |
| CFR Regulation Number | 876.5665 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-10-20 |
| Decision Date | 1995-02-28 |