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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
510(k) Number K190278
Device Name AuraGen 123 Suction Lipoplasty System (A123)
Applicant
Auragen Aesthetics, LLC
11 Dellbrook Rd.
Weston,  MA  02493
Applicant Contact Yiannis Monovoukas
Correspondent
Hogan Lovells US LLP
555 Thirteenth St. NW
Washington,  DC  20004
Correspondent Contact Randy J. Prebula
Regulation Number878.5040
Classification Product Code
MUU  
Date Received02/08/2019
Decision Date 05/03/2019
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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