The following data is part of a premarket notification filed by Willian A. Cook Australia Pty Ltd with the FDA for Single Lumen Ovum Aspiration Needles.
| Device ID | K171625 |
| 510k Number | K171625 |
| Device Name: | Single Lumen Ovum Aspiration Needles |
| Classification | Needle, Assisted Reproduction |
| Applicant | Willian A. Cook Australia Pty Ltd 95 Brandl Street Eight Mile Plains, AU 4113 |
| Contact | Gordana Pozvek |
| Correspondent | Gordana Pozvek Willian A. Cook Australia Pty Ltd 95 Brandl Street Eight Mile Plains, AU 4113 |
| Product Code | MQE |
| CFR Regulation Number | 884.6100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-06-02 |
| Decision Date | 2018-01-12 |
| Summary: | summary |