The following data is part of a premarket notification filed by Vitrolife Sweden Ab with the FDA for Spermgrad, Models 10022/10063.
| Device ID | K023403 |
| 510k Number | K023403 |
| Device Name: | SPERMGRAD, MODELS 10022/10063 |
| Classification | Media, Reproductive |
| Applicant | VITROLIFE SWEDEN AB MOLNDALSVAGEN 30 Gothenburg, SE Se-412 63 |
| Contact | Nina Arvidsson |
| Correspondent | Nina Arvidsson 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 | 2002-10-10 |
| Decision Date | 2002-12-13 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07350025914893 | K023403 | 000 |
| 07350025914886 | K023403 | 000 |
| 07350025914879 | K023403 | 000 |
| 07350025914862 | K023403 | 000 |
| 07350025910369 | K023403 | 000 |
| 07350025910352 | K023403 | 000 |
| 17350025914791 | K023403 | 000 |
| 17350025914784 | K023403 | 000 |