The following data is part of a premarket notification filed by Xvivo Perfusion Ab with the FDA for Perfadex And Perfadex With Tham.
| Device ID | K091989 |
| 510k Number | K091989 |
| Device Name: | PERFADEX AND PERFADEX WITH THAM |
| Classification | System, Perfusion, Kidney |
| Applicant | XVIVO PERFUSION AB BOX 9080 Goteborg, SE Se-40092 |
| Contact | Kjell Kjork |
| Correspondent | Kjell Kjork XVIVO PERFUSION AB BOX 9080 Goteborg, SE Se-40092 |
| Product Code | KDN |
| CFR Regulation Number | 876.5880 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-07-02 |
| Decision Date | 2010-10-01 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07350069520067 | K091989 | 000 |
| 07350069520050 | K091989 | 000 |