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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name media, electroconductive
510(k) Number K161654
Device Name NuFACE Gel Primer
Applicant
Carol Cole Company
1325 Sycamore Avenue, Suite A
Vista,  CA  92081
Applicant Contact Merle Kovacic
Correspondent
Carol Cole Company
1325 Sycamore Avenue, Suite A
Vista,  CA  92081
Correspondent Contact Merle Kovacic
Regulation Number882.1275
Classification Product Code
GYB  
Date Received06/15/2016
Decision Date 12/30/2016
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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