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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 For Removal
510(k) Number K212969
Device Name Liposaver
Applicant
Lhbiomed Co., Ltd.
#806, Medical Device Complex Center, 200, Gieopdosi-Ro,
Jijeong-Myeon
Wonju-Si,  KR 26354
Applicant Contact Seongsoo Hong
Correspondent
Plusglobal
300, Atwood St.
Pittsburgh,  PA  15213
Correspondent Contact Peter Chung
Regulation Number878.5040
Classification Product Code
QPB  
Date Received09/16/2021
Decision Date 08/07/2024
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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