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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 K081505
Device Name THERAGEM PROFESSIONAL T1002
Applicant
Medica Health, Ltd.
2842 Kelly Brooke Lane
Deerfield Beach,  FL  33442
Applicant Contact TERRI CMOREY
Correspondent
Medica Health, Ltd.
2842 Kelly Brooke Lane
Deerfield Beach,  FL  33442
Correspondent Contact TERRI CMOREY
Regulation Number890.5500
Classification Product Code
ILY  
Date Received05/29/2008
Decision Date 11/19/2008
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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