Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

510(k) Premarket Notification
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back To Search Results
Device Classification Name Pump, Breast, Powered
510(k) Number K202802
Device Name TT Electric Breast Pump, TT Double Electric Breast Pump
Applicant
Wuxi Xinzhongrui Baby Supplies Co., Ltd.
# 117 Xinhua Rd., Meicun, New Wu District,
Wuxi,  CN 214000
Applicant Contact Zhang Chunyan
Correspondent
Shanghai Landlink Medical Information Technology Co., Ltd.
Rm. 703, 705, Bldg. 1, W. Guangzhong Rd. 555, Jingan
District
Shanghai,  CN 200071
Correspondent Contact Shelley Li
Regulation Number884.5160
Classification Product Code
HGX  
Date Received09/23/2020
Decision Date 08/26/2021
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-