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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 K081720
Device Name PRECISION TDP, HEAT AND INFRARED LAMPS AND MARVEL AND WONDER LAMPS
Applicant
Prime Herbs Corporation
1872 Hartog Dr.
San Jose,  CA  95131
Applicant Contact GENEVIEVE HSIA
Correspondent
Prime Herbs Corporation
1872 Hartog Dr.
San Jose,  CA  95131
Correspondent Contact GENEVIEVE HSIA
Regulation Number890.5500
Classification Product Code
ILY  
Date Received06/18/2008
Decision Date 06/16/2009
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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