The following data is part of a premarket notification filed by Waters Instruments, Inc. with the FDA for Rm3 Renal Preservation System--control Unit.
| Device ID | K971571 |
| 510k Number | K971571 |
| Device Name: | RM3 RENAL PRESERVATION SYSTEM--CONTROL UNIT |
| Classification | System, Perfusion, Kidney |
| Applicant | WATERS INSTRUMENTS, INC. 2411 SEVENTH ST. N.W. P.O. BOX 6117 Rochester, MN 55903 -6117 |
| Contact | Dave Schollman |
| Correspondent | Dave Schollman WATERS INSTRUMENTS, INC. 2411 SEVENTH ST. N.W. P.O. BOX 6117 Rochester, MN 55903 -6117 |
| Product Code | KDN |
| CFR Regulation Number | 876.5880 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-04-30 |
| Decision Date | 1997-07-29 |
| Summary: | summary |