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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name light based over the counter wrinkle reduction
510(k) Number K120560
Device Name TRINITY WRINKLE REMOVER
Original Applicant
CAROL COLE COMPANY
16405 summer sage rd
poway,  CA  92064
Original Contact bob duffy
Regulation Number878.4810
Classification Product Code
OHS  
Date Received02/24/2012
Decision Date 11/06/2012
Decision substantially equivalent (SE)
Classification Advisory Committee General & Plastic Surgery
Review Advisory Committee General & Plastic Surgery
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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