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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 K172714
Device Name LipiVage
Applicant
Genesis Biosystems, Inc.
1500 Eagle Court
Lewisville,  TX  75057
Applicant Contact Jim Lafferty
Correspondent
Emergo Global Consulting, LLC
2500 Bee Cave Rd., Bldg. 1 Suite 300
Austin,  TX  78746
Correspondent Contact Stuart R. Goldman
Regulation Number878.5040
Classification Product Code
MUU  
Date Received09/08/2017
Decision Date 12/08/2017
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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