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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name stimulator, transcutaneous electrical, aesthetic purposes
510(k) Number K152199
Device Name RejuvatoneMD
Applicant
TROPHY SKIN, INC.
4372 KENMARE TRAIL
FRISCO,  TX  75034
Applicant Contact IMRAN KARIM
Correspondent
AEGIS REGULATORY, INC.
2424 DEMPSTER DRIVE
CORALVILLE,  IA  52241
Correspondent Contact SUE ANTHONEY-DEWET
Regulation Number882.5890
Classification Product Code
NFO  
Date Received08/06/2015
Decision Date 03/23/2016
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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