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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Pack, Hot Or Cold, Water Circulating
510(k) Number K921540
Device Name COOLING/HEATING THERAPY DEVICE
Applicant
Tempacure Home Care
8401 Battle St.
Manassas,  VA  22110
Applicant Contact WILSON II
Correspondent
Tempacure Home Care
8401 Battle St.
Manassas,  VA  22110
Correspondent Contact WILSON II
Regulation Number890.5720
Classification Product Code
ILO  
Date Received04/01/1992
Decision Date 07/21/1992
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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