The following data is part of a premarket notification filed by Renal Systems, Inc. with the FDA for Renalin (tentative.
| Device ID | K830575 |
| 510k Number | K830575 |
| Device Name: | RENALIN (TENTATIVE |
| Classification | Dialyzer Reprocessing System |
| Applicant | RENAL SYSTEMS, INC. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | LIF |
| CFR Regulation Number | 876.5820 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1983-02-23 |
| Decision Date | 1983-03-31 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10677964007979 | K830575 | 000 |
| 00677964007972 | K830575 | 000 |
| 10677964009119 | K830575 | 000 |