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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 K023934
Device Name RAPID THERMAL EXCHANGE SYSTEM
Applicant
Avacore Technologies, Inc.
251 High St., Suite B
Palo Alto,  CA  94301
Applicant Contact CRAIG COOMBS
Correspondent
Underwriters Laboratories, Inc.
333 Pfingsten Rd.
Northbrook,  IL  60062
Correspondent Contact MICHAEL KWAN
Regulation Number870.5900
Classification Product Code
DWJ  
Date Received11/26/2002
Decision Date 01/23/2003
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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