The following data is part of a premarket notification filed by Vitrolife Sweden Ab with the FDA for Rapidvit And Rapidwarm Cleave.
| Device ID | K080446 |
| 510k Number | K080446 |
| Device Name: | RAPIDVIT AND RAPIDWARM CLEAVE |
| Classification | Media, Reproductive |
| 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 | MQL |
| CFR Regulation Number | 884.6180 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | Yes |
| Date Received | 2008-02-19 |
| Decision Date | 2008-11-26 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07350025910536 | K080446 | 000 |
| 07350025910529 | K080446 | 000 |