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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 K963731
Device Name TRU-5000 THERMAL RECOVERY RADIANT HEATING UNIT
Applicant
Enthermics Medical Systems, Inc.
P.O. Box 17627
Salt Lake City,  UT  84117
Applicant Contact JAMES DIRKSEN
Correspondent
Enthermics Medical Systems, Inc.
P.O. Box 17627
Salt Lake City,  UT  84117
Correspondent Contact JAMES DIRKSEN
Regulation Number870.5900
Classification Product Code
DWJ  
Date Received09/17/1996
Decision Date 04/22/1997
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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