The following data is part of a premarket notification filed by Vitrolife Sweden Ab with the FDA for Ivf 20, Ivf 50, Ivf 500, Ivf 500 Antibiotic Free, Models 2420, 2004, 2501, 2500.
| Device ID | K991348 |
| 510k Number | K991348 |
| Device Name: | IVF 20, IVF 50, IVF 500, IVF 500 ANTIBIOTIC FREE, MODELS 2420, 2004, 2501, 2500 |
| Classification | Media, Reproductive |
| Applicant | VITROLIFE SWEDEN AB MOLNDALSVAGEN 30 Gothenburg, SE Se-412 63 |
| Contact | Eiler Anderson |
| Correspondent | Eiler Anderson VITROLIFE SWEDEN AB MOLNDALSVAGEN 30 Gothenburg, SE Se-412 63 |
| Product Code | MQL |
| CFR Regulation Number | 884.6180 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-04-19 |
| Decision Date | 2000-05-17 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07350025910291 | K991348 | 000 |