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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 K051278
Device Name GERATHERM SOS-VACUTHERM (THERMAMED SMARTCARE)
Applicant
Rg Ent., Inc.
21130 Bridge St.
Southfield,  MI  48034
Applicant Contact RONALD G LETOURNEAU
Correspondent
Rg Ent., Inc.
21130 Bridge St.
Southfield,  MI  48034
Correspondent Contact RONALD G LETOURNEAU
Regulation Number870.5900
Classification Product Code
DWJ  
Date Received05/17/2005
Decision Date 06/29/2006
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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