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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 K904998
Device Name THE BODY COOLER SYSTEM
Applicant
Costa / French
P.O Box 900
Rm.904-F
Dallas,  TX  75221
Applicant Contact STACY FRENCH
Correspondent
Costa / French
P.O Box 900
Rm.904-F
Dallas,  TX  75221
Correspondent Contact STACY FRENCH
Regulation Number890.5720
Classification Product Code
ILO  
Date Received11/06/1990
Decision Date 01/14/1991
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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