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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 BK220767
Tradenames Centrifuge Container 15 cc, Centrifuge Container 20cc, Lipocube Hybrid I, Lipocube Hybrid II, Lipocube Nano
Device Name Lipoaspirate washing system for aesthetic body contouring
Original Applicant
StemC Biotechnology Inc
merkez mah. baglar cad. no:14, b ic kap
Kagthane/ Istanbul,  34330, 
Regulation Number878.5040
Classification Product Code
QKL  
Date Received09/27/2022
Decision Date 12/21/2022
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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