The following data is part of a premarket notification filed by William A. Cook Australia Pty Ltd with the FDA for Double Lumen Ovum Aspiration Needles.
| Device ID | K171611 |
| 510k Number | K171611 |
| Device Name: | Double Lumen Ovum Aspiration Needles |
| Classification | Needle, 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 | MQE |
| CFR Regulation Number | 884.6100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-06-01 |
| Decision Date | 2017-12-15 |
| Summary: | summary |