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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name suction lipoplasty system for removal and transfer
510(k) Number BK220750
Tradenames macro st’rim™, mini st’rim™, nano st’rim™, st’rim™
Device Name Suction Lipoplasty System For Removal And Transfer
Original Applicant
THIEBAUD SAS
2 impasse des primbois
margencel,  Haute-Savoie,  74200, 
Regulation Number878.5040
Classification Product Code
QUB  
Date Received07/28/2022
Decision Date 08/26/2022
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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