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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name massager, vacuum, radio frequency induced heat
510(k) Number K162828
Device Name Winback Back 3SE
Applicant
WINBACK USA CORP
302 HIGH PLAINS DR
DRIPPING SPRINGS,  TX  78620
Applicant Contact CHEICK KONGO
Correspondent
FDC SERVICES
8708 CAPEHART COVE
AUSTIN,  TX  78733
Correspondent Contact DAVID FURR
Regulation Number878.4400
Classification Product Code
PBX  
Date Received10/07/2016
Decision Date 09/18/2017
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
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