The following data is part of a premarket notification filed by Nantong Poly Technology Co., Ltd. with the FDA for Yooeehouse Breast Pump.
| Device ID | K163183 |
| 510k Number | K163183 |
| Device Name: | Yooeehouse Breast Pump |
| Classification | Pump, Breast, Powered |
| Applicant | Nantong Poly Technology Co., Ltd. No.332, Xinxing Road, Development Zone Nantong, CN 226010 |
| Contact | Rongmin Lin |
| Correspondent | Jonathan Hu MEDWHEAT (SHANGHAI) MEDICAL TECHNOLOGY CO.,LTD.. YANGPU DISTRICT LIAOYUAN EAST ROAD SHUANGYANG FIRST SUITE NO.33 ROOM 303 Shanghai, CN 200093 |
| Product Code | HGX |
| CFR Regulation Number | 884.5160 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-11-14 |
| Decision Date | 2017-10-02 |
| Summary: | summary |