The following data is part of a premarket notification filed by Preservation Solutions, Inc. with the FDA for Costorsol.
| Device ID | K083453 |
| 510k Number | K083453 |
| Device Name: | COSTORSOL |
| Classification | System, Perfusion, Kidney |
| Applicant | PRESERVATION SOLUTIONS, INC. 4250 GROVE STREET Denver, CO 80211 |
| Contact | Neil Burris |
| Correspondent | Neil Burris PRESERVATION SOLUTIONS, INC. 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 | 2008-11-21 |
| Decision Date | 2009-01-21 |
| Summary: | summary |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() COSTORSOL 88205163 5804563 Live/Registered |
Preservation Solutions, Inc. 2018-11-26 |