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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 K071918
Device Name CHILLBUSTER PORTABLE ELECTRIC BLANKET, MODEL 8002
Applicant
Thermogear, Inc.
16337 SW Bryant Rd.
P.O. Box 1545
Lake Oswego,  OR  97035
Applicant Contact WAYNE FIELDS
Correspondent
Tuv Rheinland of North America, Inc.
12 Commerce Rd.
Newton,  CT  06470
Correspondent Contact TAMAS BORSAI
Regulation Number870.5900
Classification Product Code
DWJ  
Date Received07/12/2007
Decision Date 11/09/2007
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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