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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Suction, Lipoplasty For Removal
510(k) Number K240188
Device Name Vitruvian Liposaber
Applicant
Black & Black Surgical, Inc.
5175 S. Royal Atlanta Dr.
Tucker,  GA  30084
Applicant Contact Cynthia Rees
Correspondent
Black & Black Surgical, Inc.
5175 S. Royal Atlanta Dr.
Tucker,  GA  30084
Correspondent Contact Cynthia Rees
Regulation Number878.5040
Classification Product Code
QPB  
Date Received01/24/2024
Decision Date 09/13/2024
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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