The following data is part of a premarket notification filed by William A. Cook Australia Pty Ltd with the FDA for Sydney Ivf Follicle Flush Buffer, Sydney Ivf Fertilization Medium, Sydney Ivf Cleavage Medium, Sydney Ivf Blastocyst Medium.
| Device ID | K153290 |
| 510k Number | K153290 |
| Device Name: | Sydney IVF Follicle Flush Buffer, Sydney IVF Fertilization Medium, Sydney IVF Cleavage Medium, Sydney IVF Blastocyst Medium |
| 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 | 2015-11-13 |
| Decision Date | 2016-01-27 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00827002463080 | K153290 | 000 |
| 00827002463073 | K153290 | 000 |
| 00827002463066 | K153290 | 000 |
| 00827002463059 | K153290 | 000 |
| 00827002463028 | K153290 | 000 |
| 00827002463011 | K153290 | 000 |
| 00827002463004 | K153290 | 000 |
| 00827002462960 | K153290 | 000 |
| 00827002462953 | K153290 | 000 |