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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 BK220674
Tradename MicroAire LipoFilter® System
Device Name Lipoaspirate washing system for aesthetic body contouring
Original Applicant
MicroAire Surgical Instruments, LLC.
3590 grand forks boulevard
charlottesville,  VA  22911
Regulation Number878.5040
Classification Product Code
QKL  
Date Received02/14/2022
Decision Date 03/16/2022
Decision substantially equivalent (SE)
Classification Advisory Committee General & Plastic Surgery
Review Advisory Committee General & Plastic Surgery
Type 510(k) Special
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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