The following data is part of a premarket notification filed by William A. Cook Australia Pty, Ltd. with the FDA for Otrieva Tapered Ovum Aspiration Needle Single Lumen.
| Device ID | K141365 |
| 510k Number | K141365 |
| Device Name: | OTRIEVA TAPERED OVUM ASPIRATION NEEDLE SINGLE LUMEN |
| Classification | Needle, Assisted Reproduction |
| Applicant | WILLIAM A. COOK AUSTRALIA PTY, LTD. 95 BRANDL ST Eight Mile Plains, Queensland, AU 4113 |
| Contact | Katie-lou Buscher |
| Correspondent | Katie-lou Buscher WILLIAM A. COOK AUSTRALIA PTY, LTD. 95 BRANDL ST Eight Mile Plains, Queensland, 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 | 2014-05-23 |
| Decision Date | 2014-08-07 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00827002565425 | K141365 | 000 |
| 00827002565418 | K141365 | 000 |