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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 K852495
Device Name CAST-TECH CO. COOLING SYSTEM
Applicant
Cast-Tech Co.
493 Eastland Dr.
Twin Falls,  ID  83301
Applicant Contact JERRY MICHENER
Correspondent
Cast-Tech Co.
493 Eastland Dr.
Twin Falls,  ID  83301
Correspondent Contact JERRY MICHENER
Regulation Number890.5720
Classification Product Code
ILO  
Date Received06/12/1985
Decision Date 09/05/1985
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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