The following data is part of a premarket notification filed by Minntech Corp. with the FDA for Renalin Cold Sterilant.
| Device ID | K882564 |
| 510k Number | K882564 |
| Device Name: | RENALIN COLD STERILANT |
| Classification | Disinfectant, Medical Devices |
| 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 | LRJ |
| CFR Regulation Number | 880.6890 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-06-21 |
| Decision Date | 1989-01-09 |