The following data is part of a premarket notification filed by Vitrolife Sweden Ab with the FDA for Perfadex With Tham.
| Device ID | K081997 |
| 510k Number | K081997 |
| Device Name: | PERFADEX WITH THAM |
| Classification | System And Accessories, Isolated Heart, Transport And Preservation |
| Applicant | VITROLIFE SWEDEN AB FAKTORVAGEN 13 Kungsbacka, SE Se-434 37 |
| Contact | Kjell Kjork |
| Correspondent | Kjell Kjork VITROLIFE SWEDEN AB FAKTORVAGEN 13 Kungsbacka, SE Se-434 37 |
| Product Code | MSB |
| CFR Regulation Number | 876.5880 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-07-14 |
| Decision Date | 2008-10-09 |
| Summary: | summary |