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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name lamp, infrared, therapeutic heating
510(k) Number K121401
Device Name TENDER TOUCH
Original Applicant
SOMETECH CORPORATION
965 oakland rd.
suite 2b
lawrenceville,  GA  30044
Original Contact ki han
Regulation Number890.5500
Classification Product Code
ILY  
Date Received05/10/2012
Decision Date 05/01/2013
Decision substantially equivalent (SE)
Classification Advisory Committee Physical Medicine
Review Advisory Committee General & Plastic Surgery
statement statement
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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