The following data is part of a premarket notification filed by William A. Cook Australia Pty, Ltd. with the FDA for Cook Sydney Ivf Blastocyst Vitrification Kit, Cook Sydney Ivf Blastocyst Warming Kit.
| Device ID | K143724 |
| 510k Number | K143724 |
| Device Name: | COOK Sydney IVF Blastocyst Vitrification Kit, COOK Sydney IVF Blastocyst Warming Kit |
| Classification | Media, Reproductive |
| Applicant | WILLIAM A. COOK AUSTRALIA PTY, LTD. 95 BRANDL ST EIGHT MILE PLAINS Brisbane, AU Qld 4113 |
| Contact | Gordana Pozvek |
| Correspondent | Gordana Pozvek WILLIAM A. COOK AUSTRALIA PTY, LTD. 95 BRANDL ST EIGHT MILE PLAINS Brisbane, AU Qld 4113 |
| Product Code | MQL |
| CFR Regulation Number | 884.6180 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-12-29 |
| Decision Date | 2015-08-27 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00827002462922 | K143724 | 000 |
| 00827002462915 | K143724 | 000 |