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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 K160947
Device Name LUMIX CPS 1 IR Lamp System LUMIX CPS 2 IR Lamp System LUMIX CPS 3 IR Lamp System LUMIX CPS 4 IR Lamp System LUMIX CPS 5 IR Lamp System
Applicant
Usa Laser Biotech, Inc.
9210 Forest Hill Ave.
Suite B-3
Richmond,  VA  23235
Applicant Contact NELSON MARQUINA
Correspondent
Texas Applied Biomedical Services, Inc.
1201 Cullen Blvd.
#A
Houston,  TX  77047
Correspondent Contact M. JOYCE HEINRICH
Regulation Number890.5500
Classification Product Code
ILY  
Date Received04/05/2016
Decision Date 07/05/2016
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
Predetermined Change
Control Plan Authorized		 No
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