• 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 K162747
Device Name Proture Double Electric Breast Pump
Guangdong Horigen Mother & Baby Products Co., Ltd.
NO.8, Yi Road, Pingbei Industrial Zone, Chaoyang District
Shantou,  CN 515100
Applicant Contact Jun Deng
Giangzhou Osmunda Medical Device Technical Service Co., Ltd.
8-9th Floor, R&D Building, No. 26 Qinglan Street
Panyu District
Guangshou,  CN 510006
Correspondent Contact Mike Gu
Regulation Number884.5160
Classification Product Code
Date Received09/30/2016
Decision Date 12/08/2016
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