The following data is part of a premarket notification filed by Vitrolife Sweden Ab with the FDA for Spermfreeze Solution.
| Device ID | K113786 |
| 510k Number | K113786 |
| Device Name: | SPERMFREEZE SOLUTION |
| Classification | Media, Reproductive |
| Applicant | VITROLIFE SWEDEN AB BOX 9080 Goteborg, SE Se-40092 |
| Contact | Nina Arvidsson |
| Correspondent | Nina Arvidsson VITROLIFE SWEDEN AB BOX 9080 Goteborg, SE Se-40092 |
| Product Code | MQL |
| CFR Regulation Number | 884.6180 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | Yes |
| Date Received | 2011-12-22 |
| Decision Date | 2012-10-26 |
| Summary: | summary |