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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Powered Light Based Laser Non-Thermal Instrument With Non-Heating Effect For Adjunctive Use In Pain Therapy
510(k) Number K032816
Device Name QUANTUM LIGHT THERAPY SYSTEM
Applicant
Stargate International, Inc.
10235 S. Progress Way, #7
Parker,  CO  80134
Applicant Contact ROBERT H WALKER
Correspondent
Stargate International, Inc.
10235 S. Progress Way, #7
Parker,  CO  80134
Correspondent Contact ROBERT H WALKER
Regulation Number890.5500
Classification Product Code
NHN  
Date Received09/09/2003
Decision Date 03/26/2004
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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