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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Suction, Lipoplasty
510(k) Number K202443
Device Name Smart Kit Basic, Smart Kit Pro
Applicant
Bsl Co., Ltd.
6-13, Chilsan-Ro 237beon-Gil
Gimhae-Si,  KR
Applicant Contact Jun Seok Lee
Correspondent
Global Rqc Med Device Solutions, LLC
319 Shilling Dr.
Somerset,  NJ  08873
Correspondent Contact James W. Monroe
Regulation Number878.5040
Classification Product Code
MUU  
Date Received08/26/2020
Decision Date 03/11/2021
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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