The following data is part of a premarket notification filed by Preservation Solutions, Inc. with the FDA for Costorsol.
Device ID | K091245 |
510k Number | K091245 |
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 | 2009-04-28 |
Decision Date | 2009-06-17 |
Summary: | summary |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
COSTORSOL 88205163 5804563 Live/Registered |
Preservation Solutions, Inc. 2018-11-26 |