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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 K171588
Device Name NuBODY Skin Toning Device
Applicant
Carol Cole Company Dba Nuface
1325 Sycamore Ave.
Suite A
Vista,  CA  92081
Applicant Contact Donald Ellis
Correspondent
Carol Cole Company Dba Nuface
1325 Sycamore Ave.
Suite A
Vista,  CA  92081
Correspondent Contact Donald Ellis
Regulation Number882.5890
Classification Product Code
NFO  
Date Received05/31/2017
Decision Date 07/31/2017
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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