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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 BK220775
Tradename Procedure Tray - Lipoaspirate fat harvest and injection kit
Device Name Suction Lipoplasty System For Removal And Transfer
Original Applicant
Hydra Srl
via savonarola n°4
76  Modena,  41037,  ITALY
Regulation Number878.5040
Classification Product Code
QUB  
Date Received10/06/2022
Decision Date 01/04/2023
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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