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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 K935841
Device Name DR KOOL
Applicant
Toronto Medical Corp.
901 Dillingham Rd.
Pickering, Ontario
Canada L1w2y5,  CA
Applicant Contact BARBARA HOLT
Correspondent
Toronto Medical Corp.
901 Dillingham Rd.
Pickering, Ontario
Canada L1w2y5,  CA
Correspondent Contact BARBARA HOLT
Regulation Number890.5720
Classification Product Code
ILO  
Date Received12/07/1993
Decision Date 08/29/1994
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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