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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 K133823
Device Name NUFACE MINI DEVICE
Applicant
Carol Cole Company
1325 Sycamore Ave.
Suite A
Vista,  CA  92081
Applicant Contact Rand Daoud
Correspondent
Carol Cole Company
1325 Sycamore Ave.
Suite A
Vista,  CA  92081
Correspondent Contact Rand Daoud
Regulation Number882.5890
Classification Product Code
NFO  
Date Received12/17/2013
Decision Date 04/17/2014
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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