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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 K103472
Device Name NUFACE PLUS
Applicant
Carol Cole Company
16405 SUMMER SAGE RD
POWAY,  CA  92064
Applicant Contact BOB DUFFY
Correspondent
Carol Cole Company
16405 SUMMER SAGE RD
POWAY,  CA  92064
Correspondent Contact BOB DUFFY
Regulation Number882.5890
Classification Product Code
NFO  
Date Received11/24/2010
Decision Date 11/07/2011
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
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