The following data is part of a premarket notification filed by Wuxi Xinzhongrui Baby Supplies Co., Ltd. with the FDA for Tt Electric Breast Pump, Tt Double Electric Breast Pump.
Device ID | K202802 |
510k Number | K202802 |
Device Name: | TT Electric Breast Pump, TT Double Electric Breast Pump |
Classification | Pump, Breast, Powered |
Applicant | Wuxi Xinzhongrui Baby Supplies Co., Ltd. No. 117 Xinhua Road, Meicun, New Wu District, Wuxi, CN 214000 |
Contact | Zhang Chunyan |
Correspondent | Shelley Li Shanghai Landlink Medical Information Technology Co., Ltd. Room 703, 705, Building 1, West Guangzhong Road 555, Jingan District Shanghai, CN 200071 |
Product Code | HGX |
CFR Regulation Number | 884.5160 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2020-09-23 |
Decision Date | 2021-08-26 |