The following data is part of a premarket notification filed by Preservation Solutions, Inc. with the FDA for Costorsol Plus G.
| Device ID | K151728 |
| 510k Number | K151728 |
| Device Name: | CoStorSol Plus G |
| Classification | System, Perfusion, Kidney |
| Applicant | PRESERVATION SOLUTIONS, INC. 1099 PROCTOR DRIVE Elkhorn, WI 53121 |
| Contact | Gary Swanson |
| Correspondent | Neil Burris NEIL BURRIS & ASSOCIATES 4250 GROVE STREET Denver, CO 80211 |
| Product Code | KDN |
| CFR Regulation Number | 876.5880 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-06-26 |
| Decision Date | 2015-09-18 |
| Summary: | summary |