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U.S. Department of Health and Human Services

510(k) Premarket Notification
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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
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