Hi Bebe Plus

Pump, Breast, Powered

BISTOS CO., LTD.

The following data is part of a premarket notification filed by Bistos Co., Ltd. with the FDA for Hi Bebe Plus.

Pre-market Notification Details

Device IDK160274
510k NumberK160274
Device Name:Hi Bebe Plus
ClassificationPump, Breast, Powered
Applicant BISTOS CO., LTD. 7th Fl., A Bldg., Woolim Lions Valley 5-cha, 302, Galmachi-ro, Jungwon-gu Seongnam,  KR 13201
ContactJenny Cho
CorrespondentDave Kim
MTECH GROUP 8310 BUFFALO SPEEDWAY Houston,  TX  77025
Product CodeHGX  
CFR Regulation Number884.5160 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2016-02-02
Decision Date2016-09-01
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
10887529000165 K160274 000
00887529000151 K160274 000
00887529000465 K160274 000

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