MAPERSOL
System, Perfusion, Kidney
PRESERVATION SOLUTIONS, INC.
The following data is part of a premarket notification filed by Preservation Solutions, Inc. with the FDA for Mapersol.
Pre-market Notification Details
| Device ID | K080432 |
| 510k Number | K080432 |
| Device Name: | MAPERSOL |
| 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 | 2008-02-19 |
| Decision Date | 2008-08-08 |
| Summary: | summary |
NIH GUDID Devices
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10810805000177 | K080432 | 000 |
| 10810805000108 | K080432 | 000 |
| 10810805000092 | K080432 | 000 |
Trademark Results [MAPERSOL]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 MAPERSOL 88441386 5948376 Live/Registered |
Preservation Solutions, Inc. 2019-05-22 |
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