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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 K022903
Device Name CHILLBUSTER
Applicant
Microtek Medical, Inc.
512 Lehmberg Rd.
Columbus,  MS  39702
Applicant Contact THOMAS BONNER
Correspondent
Microtek Medical, Inc.
512 Lehmberg Rd.
Columbus,  MS  39702
Correspondent Contact THOMAS BONNER
Regulation Number870.5900
Classification Product Code
DWJ  
Date Received09/03/2002
Decision Date 11/27/2002
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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