The following data is part of a premarket notification filed by William A. Cook Australia Pty Ltd with the FDA for Sydney Ivf Sperm Medium, Sydney Ivf Sperm Gradient Kit, Sydney Ivf Spermient.
| Device ID | K152782 |
| 510k Number | K152782 |
| Device Name: | SYDNEY IVF SPERM MEDIUM, SYDNEY IVF SPERM GRADIENT KIT, SYDNEY IVF SPERMIENT |
| 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 | 2015-09-25 |
| Decision Date | 2015-12-21 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00827002463165 | K152782 | 000 |
| 00827002463158 | K152782 | 000 |
| 00827002463141 | K152782 | 000 |
| 00827002463134 | K152782 | 000 |
| 00827002463127 | K152782 | 000 |
| 00827002463110 | K152782 | 000 |
| 00827002463103 | K152782 | 000 |