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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 K132016
Device Name LUMIX 3 PLUS AND LUMIX 3 ULTRA SYSTEM
Applicant
TEXAS APPLIED BIOMEDICAL SERVICES, INC.
12101-A CULLEN BLVD.
SUITE A
HOUSTON,  TX  77047
Applicant Contact M. JOYCE HEINRICH
Correspondent
TEXAS APPLIED BIOMEDICAL SERVICES, INC.
12101-A CULLEN BLVD.
SUITE A
HOUSTON,  TX  77047
Correspondent Contact M. JOYCE HEINRICH
Regulation Number890.5500
Classification Product Code
ILY  
Date Received07/01/2013
Decision Date 06/02/2014
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Physical Medicine
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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