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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 BK220726
Tradename IntelliFat Disposable Adipose Tissue Harvesting and Transfer Kit, IntelliFat Body On Demand (BOD) Kit (K210528)
Device Name Lipoaspirate washing system for aesthetic body contouring
Original Applicant
Millennium Medical Technologies Inc (DBA Cellmyx)
6352 corte del abeto ste a
carlsbad,  CA  92011
Regulation Number878.5040
Classification Product Code
QKL  
Secondary Product Code
QUB 
Date Received04/07/2022
Decision Date 03/16/2022
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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