The following data is part of a premarket notification filed by Renal Systems, Inc. with the FDA for Renal Systems Peritoneal Access System.
| Device ID | K844108 |
| 510k Number | K844108 |
| Device Name: | RENAL SYSTEMS PERITONEAL ACCESS SYSTEM |
| Classification | System, Peritoneal, Automatic Delivery |
| 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 | FKX |
| CFR Regulation Number | 876.5630 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-10-23 |
| Decision Date | 1985-01-07 |