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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 K070024
Device Name THOR VR SINGLE DIODE LASER TREATMENT PROBE, MODEL 200 MW SINGLE VR DIODE PROBE
Applicant
Thor International
12101 Cullen Blvd.
Suite A
Houston,  TX  77047
Applicant Contact M. JOYCE HEINRICH
Correspondent
Thor International
12101 Cullen Blvd.
Suite A
Houston,  TX  77047
Correspondent Contact M. JOYCE HEINRICH
Regulation Number890.5500
Classification Product Code
ILY  
Date Received01/03/2007
Decision Date 05/16/2007
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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