The following data is part of a premarket notification filed by Medical Technologies International, Inc. with the FDA for Rinse Machine Kr-4 Kidney Rinse-4.
| Device ID | K850799 |
| 510k Number | K850799 |
| Device Name: | RINSE MACHINE KR-4 KIDNEY RINSE-4 |
| Classification | Dialyzer Reprocessing System |
| Applicant | MEDICAL TECHNOLOGIES INTERNATIONAL, INC. 3922 NORTH SAGIHAW ST. Flint Mi, MI 48505 |
| Product Code | LIF |
| CFR Regulation Number | 876.5820 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-02-27 |
| Decision Date | 1985-07-29 |