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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 K030226
Device Name THOR DDII 830CL3 LASER SYSTEM
Applicant
Thor Intl.
12101 Cullen Blvd. # A
Houston,  TX  77047
Applicant Contact M. JOYCE HEINRICH
Correspondent
Thor Intl.
12101 Cullen Blvd. # A
Houston,  TX  77047
Correspondent Contact M. JOYCE HEINRICH
Regulation Number890.5500
Classification Product Code
NHN  
Date Received01/22/2003
Decision Date 02/10/2003
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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