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 K160274
Device Name Hi bebe plus
Applicant
BISTOS CO., LTD.
7th Fl., A Bldg., Woolim Lions Valley 5-cha, 302,
Galmachi-ro, Jungwon-gu
Seongnam,  KR 13201
Applicant Contact Jenny Cho
Correspondent
MTECH GROUP
8310 BUFFALO SPEEDWAY
HOUSTON,  TX  77025
Correspondent Contact Dave Kim
Regulation Number884.5160
Classification Product Code
HGX  
Date Received02/02/2016
Decision Date 09/01/2016
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
Predetermined Change
Control Plan Authorized		 No
-
-