The following data is part of a premarket notification filed by William A. Cook Australia Pty Ltd with the FDA for Towako Transmyometrial Embryo Transfer Set.
| Device ID | K173431 |
| 510k Number | K173431 |
| Device Name: | Towako Transmyometrial Embryo Transfer Set |
| Classification | Catheter, Assisted Reproduction |
| 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 | MQF |
| CFR Regulation Number | 884.6110 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-11-02 |
| Decision Date | 2018-05-18 |
| Summary: | summary |