The following data is part of a premarket notification filed by Texas Medical Devices, Inc. with the FDA for Automatic Dialyzer Reprocessor #adr-22.
| Device ID | K820695 |
| 510k Number | K820695 |
| Device Name: | AUTOMATIC DIALYZER REPROCESSOR #ADR-22 |
| Classification | Dialyzer Reprocessing System |
| Applicant | TEXAS MEDICAL DEVICES, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | LIF |
| CFR Regulation Number | 876.5820 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1982-03-12 |
| Decision Date | 1982-04-29 |