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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 K943844
Device Name TOTALLY COOL(TM) TC-1
Applicant
Electro Science Technologies, Inc.
601 Thirteenth St. NW
Washington,  DC  20005
Applicant Contact TERRY G MAHN
Correspondent
Electro Science Technologies, Inc.
601 Thirteenth St. NW
Washington,  DC  20005
Correspondent Contact TERRY G MAHN
Regulation Number890.5720
Classification Product Code
ILO  
Date Received06/17/1994
Decision Date 02/09/1995
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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