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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Pad, Heating, Powered
510(k) Number K791154
Device Name THERMAL CONDITIONING SYSTEM
Applicant
Acurex Aerotherm
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
Acurex Aerotherm
803 N. Front St. Suite 3
Mchenry,  IL  60050
Regulation Number890.5740
Classification Product Code
IRT  
Date Received06/20/1979
Decision Date 10/09/1979
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Physical Medicine
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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