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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Thermal Regulating
510(k) Number K062794
Device Name PRN THERMALCARE, MODEL 3000
Applicant
American Healthcare Products, Inc.
3220 S. Hanford St.
Seattle,  WA  98144
Applicant Contact KENT D ELLIS
Correspondent
American Healthcare Products, Inc.
3220 S. Hanford St.
Seattle,  WA  98144
Correspondent Contact KENT D ELLIS
Regulation Number870.5900
Classification Product Code
DWJ  
Date Received09/18/2006
Decision Date 12/07/2006
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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