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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
Applicant
Sometech Corporation
965 Oakland Rd.
Suite 2b
Lawrenceville,  GA  30044
Applicant Contact KI HAN
Correspondent
Sometech Corporation
965 Oakland Rd.
Suite 2b
Lawrenceville,  GA  30044
Correspondent Contact KI HAN
Regulation Number890.5500
Classification Product Code
ILY  
Date Received05/10/2012
Decision Date 05/01/2013
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Physical Medicine
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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