The following data is part of a premarket notification filed by Alcide Corp. with the FDA for Rennew-d Sporicide/disinfectant For Hemodialyzers.
| Device ID | K853413 |
| 510k Number | K853413 |
| Device Name: | RENNEW-D SPORICIDE/DISINFECTANT FOR HEMODIALYZERS |
| Classification | Dialyzer Reprocessing System |
| Applicant | ALCIDE CORP. ONE WILLARD RD. Norwalk, CT 06851 |
| Contact | Harry M Kaufman |
| Correspondent | Harry M Kaufman ALCIDE CORP. ONE WILLARD RD. Norwalk, CT 06851 |
| Product Code | LIF |
| CFR Regulation Number | 876.5820 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-08-14 |
| Decision Date | 1985-09-06 |