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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 K083135
Device Name MODIFICATION TO CHILLBUSTER PORTABLE ELECTRIC BLANKET , MODEL 8002
Applicant
Thermogear, Inc.
1307 Moore St., Suite 804
Brookings,  OR  97415
Applicant Contact WAYNE FIELDS, PHD
Correspondent
Tuv Rheinland of North America, Inc.
12 Commerce Rd.
Newton,  CT  06470
Regulation Number870.5900
Classification Product Code
DWJ  
Date Received10/23/2008
Decision Date 10/31/2008
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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