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 K132882
Device Name ELECTRIC BREAST PUMP
Applicant
SHANTOU XINGHE ELECTRICAL APPARATUSES CO., LTD
7TH FLOOR, JINGUI BUSINESS BLDG, NO.982 CONGYUN RD
BAIYUN DISTRICT
GUANGZHOU, GUANGDONG,  CN 510420
Applicant Contact MIKE GU
Correspondent
SHANTOU XINGHE ELECTRICAL APPARATUSES CO., LTD
7TH FLOOR, JINGUI BUSINESS BLDG, NO.982 CONGYUN RD
BAIYUN DISTRICT
GUANGZHOU, GUANGDONG,  CN 510420
Correspondent Contact MIKE GU
Regulation Number884.5160
Classification Product Code
HGX  
Date Received09/13/2013
Decision Date 04/24/2014
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
-
-