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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 K200446
Device Name STERIS Patient Warming System
Applicant
STERIS Corporation
5960 Heisley Rd.
Mentor,  OH  44060
Applicant Contact Gregory Land
Correspondent
STERIS Corporation
5960 Heisley Rd.
Mentor,  OH  44060
Correspondent Contact Gregory Land
Regulation Number870.5900
Classification Product Code
DWJ  
Date Received02/24/2020
Decision Date 06/13/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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