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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name fat reducing low level laser
510(k) Number K121690
Device Name ETCHONIA ZERONA ARMS
Original Applicant
ERCHONIA CORPORATION
33 golden eagle lane
littleton,  CO  80127
Original Contact kevin walls
Regulation Number878.5400
Classification Product Code
OLI  
Date Received06/07/2012
Decision Date 08/23/2012
Decision substantially equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
statement statement
Type Traditional
Reviewed by Third Party No
Combination Product No
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