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510(k) K212969

Device
Liposaver
Applicant
Lhbiomed Co., Ltd.
510(k) number
K212969
Product code
QPB
Decision
Substantially Equivalent (SESE)
Decision date
2024-08-07
Date received
2021-09-16
Regulation
878.5040
Classification name
System, Suction, Lipoplasty For Removal
Medical specialty
General, Plastic Surgery
Review panel
General, Plastic Surgery
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Seongsoo Hong
Address
#806, Medical Device Complex Center, 200, Gieopdosi-Ro, Jijeong-Myeon Wonju-Si KR 26354 26354

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

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K171286PAL Multi-Use Cannulas and PAL Manual WandMicroaire Surgical Instruments, LLC2017-10-13
K170629VITRUVIAN INFILTRATION PUMPBlack & Black Surgical, Inc.2017-06-22