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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 K201680
Device Name NuFACE Mini Plus
Applicant
Carole Cole Company
1325 Sycamore Ave.
Suite A
Vista,  CA  92081
Applicant Contact Danielle Barker Fernandes
Correspondent
Carole Cole Company
1325 Sycamore Ave.
Suite A
Vista,  CA  92081
Correspondent Contact Bob Duffy
Regulation Number882.5890
Classification Product Code
NFO  
Date Received06/22/2020
Decision Date 02/19/2021
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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