The following data is part of a premarket notification filed by Vitrolife A/s with the FDA for Embryoslide Culture Dish.
| Device ID | K150961 |
| 510k Number | K150961 |
| Device Name: | EmbryoSlide Culture Dish |
| Classification | Labware, Assisted Reproduction |
| Applicant | VITROLIFE A/S JENS JUULS VEJ 20 Viby J, DK Dk-8260 |
| Contact | Belinda Dueholm |
| Correspondent | Belinda Dueholm VITROLIFE A/S JENS JUULS VEJ 20 Viby J, DK Dk-8260 |
| Product Code | MQK |
| CFR Regulation Number | 884.6160 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-04-10 |
| Decision Date | 2015-12-04 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05712714663505 | K150961 | 000 |