The following data is part of a premarket notification filed by Vitrolife Sweden Ab with the FDA for Icsi-100.
| Device ID | K043116 |
| 510k Number | K043116 |
| Device Name: | ICSI-100 |
| Classification | Media, Reproductive |
| Applicant | VITROLIFE SWEDEN AB FAKTORVAGEN 13 Kungsbacka, SE Se-434 37 |
| Contact | Morgan Hugosson |
| Correspondent | Morgan Hugosson 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 | 2004-11-10 |
| Decision Date | 2005-01-13 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 17350025910274 | K043116 | 000 |