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 (k-sibv-5000), Warming (k-sibw-5000) Kits.
| Device ID | K082363 |
| 510k Number | K082363 |
| Device Name: | COOK SYDNEY IVF BLASTOCYST VITRIFICATION (K-SIBV-5000), WARMING (K-SIBW-5000) KITS |
| Classification | Media, Reproductive |
| Applicant | WILLIAM A. COOK AUSTRALIA PTY, LTD. 12 ELECTRONICS ST. Eight Mile Plains, Qld, AU 4113 |
| Contact | Gus Taddeo |
| Correspondent | Gus Taddeo WILLIAM A. COOK AUSTRALIA PTY, LTD. 12 ELECTRONICS ST. Eight Mile Plains, Qld, 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 | 2008-08-18 |
| Decision Date | 2009-04-29 |
| Summary: | summary |