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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 K923643
Device Name MEDICOOL
Applicant
Micromedic Systems
3689 Mando Ct.
Coleman,  MI  48618
Applicant Contact TOMAS E DUNN
Correspondent
Micromedic Systems
3689 Mando Ct.
Coleman,  MI  48618
Correspondent Contact TOMAS E DUNN
Regulation Number890.5720
Classification Product Code
ILO  
Date Received07/21/1992
Decision Date 03/31/1993
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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