The following data is part of a premarket notification filed by Biodynamics Corp. with the FDA for Adr-22 Automatic Dialyzer Reprocessor.
| Device ID | K874034 |
| 510k Number | K874034 |
| Device Name: | ADR-22 AUTOMATIC DIALYZER REPROCESSOR |
| Classification | Dialyzer Reprocessing System |
| Applicant | BIODYNAMICS CORP. 6611 PORTWEST DR. SUITE 190 Houston, TX 77024 |
| Contact | Richard L Benson |
| Correspondent | Richard L Benson BIODYNAMICS CORP. 6611 PORTWEST DR. SUITE 190 Houston, TX 77024 |
| Product Code | LIF |
| CFR Regulation Number | 876.5820 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-10-05 |
| Decision Date | 1987-10-23 |