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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 K201782
Device Name NuFace Trinity Plus Device
Applicant
Carol Cole Company dba NuFACE
1325 Sycamore Avenue, Suite A
Vista,  CA  92081
Applicant Contact Danielle Barker Fernandes
Correspondent
Bob Duffy Associates, Inc.
16405 Summer Sage Rd.
Poway,  CA  92064
Correspondent Contact Bob Duffy
Regulation Number882.5890
Classification Product Code
NFO  
Date Received06/30/2020
Decision Date 01/22/2021
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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