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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 K032787
Device Name NEUROLASE, MODELS 150V, 150C, 1064
Applicant
Spectrum Laser & Technologies
4980 A Centennial Blvd.
Colorado Springs,  CO  80919
Applicant Contact THOMAS R RADEBAUGH
Correspondent
Spectrum Laser & Technologies
4980 A Centennial Blvd.
Colorado Springs,  CO  80919
Correspondent Contact THOMAS R RADEBAUGH
Regulation Number890.5500
Classification Product Code
ILY  
Date Received09/08/2003
Decision Date 11/20/2003
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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