The following data is part of a premarket notification filed by William A. Cook Australia Pty Ltd with the FDA for Sydney Ivf Gamete Buffer.
| Device ID | K153478 |
| 510k Number | K153478 |
| Device Name: | Sydney IVF Gamete Buffer |
| 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 | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | Yes |
| Date Received | 2015-12-02 |
| Decision Date | 2016-08-15 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00827002463202 | K153478 | 000 |
| 00827002463189 | K153478 | 000 |
| 00827002463172 | K153478 | 000 |