The following data is part of a premarket notification filed by Guangzhou Jinxinbao Electronic Co.,ltd with the FDA for Breast Pump.
| Device ID | K150923 |
| 510k Number | K150923 |
| Device Name: | Breast Pump |
| Classification | Pump, Breast, Powered |
| Applicant | Guangzhou Jinxinbao Electronic Co.,Ltd No.38 Huanzhen Xi Road, Dagang Town, Nansha Guangzhou,guangdong, CN 511470 |
| Contact | Jiacheng Guo |
| Correspondent | Helen Nan Wenzhou Cytech Information Service Co., Ltd. Room302, NO.21 Building, Kaiyu Garden, Xishan South Road Wenzhou, Zhejiang, CN 325000 |
| Product Code | HGX |
| CFR Regulation Number | 884.5160 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-04-06 |
| Decision Date | 2015-11-06 |
| Summary: | summary |