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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 K232502
Device Name Cocoon Convective Warming System, Model CWS7000
Applicant
Care Essentials Pty, Ltd.
103 Mornington St.
North Geelong,  AU 3215
Applicant Contact Abhay Sinha
Correspondent
Care Essentials Pty, Ltd.
103 Mornington St.
North Geelong,  AU 3215
Correspondent Contact Abhay Sinha
Regulation Number870.5900
Classification Product Code
DWJ  
Date Received08/18/2023
Decision Date 02/21/2024
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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