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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 K940858
Device Name THERA COOL HOME UNIT/COOLPAC(AMBU/RESERVIOR UNITS)
Applicant
Innovation Sports, Inc.
#7 Chrysler
Irvine,  CA  92718
Applicant Contact TERRY L SHIRLEY
Correspondent
Innovation Sports, Inc.
#7 Chrysler
Irvine,  CA  92718
Correspondent Contact TERRY L SHIRLEY
Regulation Number890.5720
Classification Product Code
ILO  
Date Received02/23/1994
Decision Date 07/12/1994
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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