The following data is part of a premarket notification filed by Minntech Corp. with the FDA for Renatron Ii Dialyzer Reprocessing System Rs 8330.
| Device ID | K904210 |
| 510k Number | K904210 |
| Device Name: | RENATRON II DIALYZER REPROCESSING SYSTEM RS 8330 |
| Classification | Dialyzer Reprocessing 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 | LIF |
| CFR Regulation Number | 876.5820 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-09-12 |
| Decision Date | 1990-11-27 |