Hi Bebe Super (Models BT-150S And BT-150L)

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 Super (models Bt-150s And Bt-150l).

Pre-market Notification Details

Device IDK200675
510k NumberK200675
Device Name:Hi Bebe Super (Models BT-150S And BT-150L)
ClassificationPump, Breast, Powered
Applicant Bistos Co., Ltd. 7th Fl. A Bldg., Woolim Lions Valley 5-cha, 302, Galmachi-ro, Jungwon-gu Seongnam-si,  KR 13201
ContactHae Sun Jeong
CorrespondentDave Kim
Mtech Group 7707 Fannin St. Ste 200 Houston,  TX  77054
Product CodeHGX  
CFR Regulation Number884.5160 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-03-16
Decision Date2021-02-10

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