The following data is part of a premarket notification filed by Waters Instruments, Inc. with the FDA for Rm3 Renal Preservation System.
| Device ID | K042224 |
| 510k Number | K042224 |
| Device Name: | RM3 RENAL PRESERVATION SYSTEM |
| Classification | System, Perfusion, Kidney |
| Applicant | WATERS INSTRUMENTS, INC. 13705 26TH AVENUE N. SUITE 102 Minneapolis, MN 55441 -3644 |
| Contact | Dave Schollman |
| Correspondent | Dave Schollman WATERS INSTRUMENTS, INC. 13705 26TH AVENUE N. SUITE 102 Minneapolis, MN 55441 -3644 |
| Product Code | KDN |
| CFR Regulation Number | 876.5880 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-08-17 |
| Decision Date | 2004-10-22 |
| Summary: | summary |