The following data is part of a premarket notification filed by Genea Biomedx Pty Ltd with the FDA for Gems Vitrification Set, Gems Warming Set.
| Device ID | K162409 |
| 510k Number | K162409 |
| Device Name: | Gems Vitrification Set, Gems Warming Set |
| Classification | Media, Reproductive |
| Applicant | GENEA BIOMEDX PTY LTD LEVEL 2, 321 KENT STREET Sydney, AU 2000 |
| Contact | Kea Dent |
| Correspondent | Roger Gray DONAWA LIFESCIENCE CONSULTING PIAZZA ALBANIA 10 Rome, IT 00153 |
| Product Code | MQL |
| CFR Regulation Number | 884.6180 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | Yes |
| Date Received | 2016-08-29 |
| Decision Date | 2017-05-24 |
| Summary: | summary |