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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 K132454
Device Name VITAHEAT PATIENT WARMING SYSTEM
Applicant
Vitaheat Medical, LLC
1585 Beverly Dr. #121
Aurora,  IL  60502
Applicant Contact JACK SLOVICK
Correspondent
Regulatory Technology Services, LLC
1000 Westgate Dr. Suite #510k
Saint Paul,  MN  55114
Regulation Number870.5900
Classification Product Code
DWJ  
Date Received08/06/2013
Decision Date 10/04/2013
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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