The following data is part of a premarket notification filed by Waters Instruments, Inc. with the FDA for Rm3 Renal Preservation System.
| Device ID | K053169 |
| 510k Number | K053169 |
| Device Name: | RM3 RENAL PRESERVATION SYSTEM |
| Classification | Container, Transport, Kidney |
| Applicant | WATERS INSTRUMENTS, INC. 2112 15TH ST. N.W., SUITE A Rochester, MN 55901 |
| Contact | Dave Schollman |
| Correspondent | Dave Schollman WATERS INSTRUMENTS, INC. 2112 15TH ST. N.W., SUITE A Rochester, MN 55901 |
| Product Code | KDK |
| CFR Regulation Number | 876.5880 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-11-14 |
| Decision Date | 2006-01-17 |
| Summary: | summary |