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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 K122711
Device Name FACIAL SPA
Applicant
NUSKIN
ONE METRO CENTER 700
12TH STREET, SUITE 900
WASHINGTON,  DC  20005
Applicant Contact PAUL RUBIN
Correspondent
NUSKIN
ONE METRO CENTER 700
12TH STREET, SUITE 900
WASHINGTON,  DC  20005
Correspondent Contact PAUL RUBIN
Regulation Number882.5890
Classification Product Code
NFO  
Date Received09/04/2012
Decision Date 09/17/2013
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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