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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 K182424
Device Name NuFACE FIX 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 Received09/06/2018
Decision Date 12/18/2018
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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