The following data is part of a premarket notification filed by Willow Innovations, Inc. with the FDA for Lucy Breast Pump.
| Device ID | K213311 |
| 510k Number | K213311 |
| Device Name: | Lucy Breast Pump |
| Classification | Pump, Breast, Powered |
| Applicant | Willow Innovations, Inc. 1975 W. El Camino Real, Suite 306 Mountain View, CA 94040 |
| Contact | Nelson Lam |
| Correspondent | Dave Yungvirt THIRD PARTY REVIEW GROUP, LLC 25 Independence Blvd Warren, NJ 07059 |
| Product Code | HGX |
| CFR Regulation Number | 884.5160 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2021-10-04 |
| Decision Date | 2022-02-09 |