The following data is part of a premarket notification filed by Exploramed Nc7, Inc. with the FDA for Willow Wearable Breast Pump 2.0.
| Device ID | K191577 |
| 510k Number | K191577 |
| Device Name: | Willow Wearable Breast Pump 2.0 |
| Classification | Pump, Breast, Powered |
| Applicant | Exploramed NC7, Inc. 1975 W. El Camino Real, Suite 306 Mountain View, CA 94040 |
| Contact | Steve Holmes |
| Correspondent | Steve Holmes Exploramed NC7, Inc. 1975 W. El Camino Real, Suite 306 Mountain View, CA 94040 |
| Product Code | HGX |
| CFR Regulation Number | 884.5160 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-06-14 |
| Decision Date | 2019-09-06 |
| Summary: | summary |