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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 BK220686
Tradename LIPOKIT WITH DISPOSABLE 50CC AFT SYRINGE MODEL ZLK-100 (K083455)
Device Name Lipoaspirate washing system for aesthetic body contouring
Original Applicant
Medi-Khan USA INC
655 north berry st
brea,  CA  92821
Regulation Number878.5040
Classification Product Code
QKL  
Secondary Product Code
QUB 
Date Received03/28/2022
Decision Date 05/18/2009
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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