The following data is part of a premarket notification filed by Renal Systems, Inc. with the FDA for Actril For Kidney Machine Disinfectant.
| Device ID | K861730 |
| 510k Number | K861730 |
| Device Name: | ACTRIL FOR KIDNEY MACHINE DISINFECTANT |
| Classification | System, Dialysate Delivery, Central Multiple Patient |
| Applicant | RENAL SYSTEMS, INC. 14905 28TH AVE. N. Minneapolis, MN 55441 |
| Contact | Leroy J Fischbach |
| Correspondent | Leroy J Fischbach RENAL SYSTEMS, INC. 14905 28TH AVE. N. Minneapolis, MN 55441 |
| Product Code | FKQ |
| CFR Regulation Number | 876.5820 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-05-06 |
| Decision Date | 1987-06-09 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 40677964016736 | K861730 | 000 |
| 10677964105972 | K861730 | 000 |
| 10677964009119 | K861730 | 000 |
| 10677964008259 | K861730 | 000 |
| 30677964000295 | K861730 | 000 |
| 30677964000240 | K861730 | 000 |
| 40677964023987 | K861730 | 000 |