The following data is part of a premarket notification filed by Vitrolife Sweden Ab with the FDA for G-1 V5.
| Device ID | K081114 |
| 510k Number | K081114 |
| Device Name: | G-1 V5 |
| 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 | 2008-04-18 |
| Decision Date | 2008-09-16 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07350025910581 | K081114 | 000 |
| 07350025910451 | K081114 | 000 |
| 07350025910444 | K081114 | 000 |