The following data is part of a premarket notification filed by William A. Cook Australia Pty Ltd with the FDA for Sydney Ivf Culture Oil.
| Device ID | K170257 |
| 510k Number | K170257 |
| Device Name: | Sydney IVF Culture Oil |
| Classification | Media, Reproductive |
| Applicant | William A. Cook Australia Pty Ltd 95 Brandl Street Eight Mile Plains, AU 4113 |
| Contact | Gordana Pozvek |
| Correspondent | Gordana Pozvek William A. Cook Australia Pty Ltd 95 Brandl Street Eight Mile Plains, AU 4113 |
| Product Code | MQL |
| CFR Regulation Number | 884.6180 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-01-27 |
| Decision Date | 2017-02-24 |
| Summary: | summary |