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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 K991684
Device Name CHILLBUSTER PORTABLE ELECTRIC BLANKET SYSTEM, MODEL 8001
Applicant
Thermogear, Inc.
18005 Lower Boones Ferry Rd.
Tigard,  OR  97224
Applicant Contact R. WAYNE FIELDS
Correspondent
Thermogear, Inc.
18005 Lower Boones Ferry Rd.
Tigard,  OR  97224
Correspondent Contact R. WAYNE FIELDS
Regulation Number870.5900
Classification Product Code
DWJ  
Date Received05/17/1999
Decision Date 03/01/2000
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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