Smart Kit Basic, Smart Kit Pro

System, Suction, Lipoplasty

BSL Co., Ltd

The following data is part of a premarket notification filed by Bsl Co., Ltd with the FDA for Smart Kit Basic, Smart Kit Pro.

Pre-market Notification Details

Device IDK202443
510k NumberK202443
Device Name:Smart Kit Basic, Smart Kit Pro
ClassificationSystem, Suction, Lipoplasty
Applicant BSL Co., Ltd 6-13, Chilsan-ro 237beon-gil Gimhae-si,  KR
ContactJun Seok Lee
CorrespondentJames W. Monroe
Global RQC Med Device Solutions, LLC. 319 Shilling Dr. Somerset,  NJ  08873
Product CodeMUU  
CFR Regulation Number878.5040 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-08-26
Decision Date2021-03-11

© 2021 FDA.report
This site is not affiliated with or endorsed by the FDA.