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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 K181671
Device Name Cocoon Convective Warming System
Applicant
Care Essentials Pty, Ltd.
25 Slevin St.
North Geelong,  AU 3215
Applicant Contact Abhay Sinha
Correspondent
Care Essentials Pty, Ltd.
25 Slevin St.
North Geelong,  AU 3215
Correspondent Contact Abhay Sinha
Regulation Number870.5900
Classification Product Code
DWJ  
Date Received06/25/2018
Decision Date 05/02/2019
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Statement Statement
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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