The following data is part of a premarket notification filed by Coopersurgical Inc. with the FDA for Wallace Dual Lumen Oocyte Recovery System.
| Device ID | K182959 |
| 510k Number | K182959 |
| Device Name: | Wallace Dual Lumen Oocyte Recovery System |
| Classification | Needle, Assisted Reproduction |
| Applicant | CooperSurgical Inc. 95 Corporate Drive Trumbull, CT 06611 |
| Contact | Roaida Johnson |
| Correspondent | Christine Kupchick CooperSurgical Inc. 95 Corporate Drive Trumbull, CT 06611 |
| Product Code | MQE |
| CFR Regulation Number | 884.6100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-10-25 |
| Decision Date | 2019-05-10 |