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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 K203085
Device Name NOVA Patient Warming System
Applicant
Encompass Group, LLC
615 Macon St.
Mcdonough,  GA  30253
Applicant Contact Eric Howard
Correspondent
Third Party Review Group, LLC
25 Independence Blvd.
Warren,  NJ  07059
Correspondent Contact Dave Yungvirt
Regulation Number870.5900
Classification Product Code
DWJ  
Date Received10/13/2020
Decision Date 11/12/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Statement Statement
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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