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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name lipoaspirate washing system for aesthetic body contouring
510(k) Number BK220707
Tradename Lipogems System (K161636)
Device Name Lipoaspirate washing system for aesthetic body contouring
Original Applicant
Lipogems International SpA
viale bianca maria 24
milan,  Milano,  20129, 
Regulation Number878.5040
Classification Product Code
QKL  
Date Received03/31/2022
Decision Date 11/04/2016
Decision substantially equivalent (SE)
Classification Advisory Committee General & Plastic Surgery
Review Advisory Committee General & Plastic Surgery
Type 510(k) Traditional
Total Product Life Cycle (TPLC) TPLC Device Report
Reviewed by Third Party No
Expedited Review No
Combination Product No
In Vitro Product No
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