The following data is part of a premarket notification filed by Willam A. Cook Australia Pty Ltd with the FDA for Sydney Ivf Pvp.
| Device ID | K152440 |
| 510k Number | K152440 |
| Device Name: | Sydney IVF PVP |
| Classification | Media, Reproductive |
| Applicant | WILLAM A. COOK AUSTRALIA PTY LTD 95 BRANDL STREET Eight Mile Plains, AU 4113 |
| Contact | Gordana Pozvek |
| Correspondent | Gordana Pozvek WILLAM 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 | 2015-08-27 |
| Decision Date | 2015-09-23 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00827002463035 | K152440 | 000 |