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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 K945853
Device Name THERMOTEK H-300
Applicant
Thermotek, Inc.
3330 Earhart Dr., Suite 212
Carrollton,  TX  75006
Applicant Contact JOHN F SKINNER
Correspondent
Thermotek, Inc.
3330 Earhart Dr., Suite 212
Carrollton,  TX  75006
Correspondent Contact JOHN F SKINNER
Regulation Number890.5720
Classification Product Code
ILO  
Date Received10/31/1994
Decision Date 10/05/1995
Decision SUBSTANTIALLY EQUIVALENT FOR SOME INDICATIONS (SN)
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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