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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 K140635
Device Name COCOON CONVECTIVE WARMING SYSTEM
Applicant
CARE ESSENTIALS PTY LTD
SUITE 2/ 36-38 GLEN OSMOND ROAD
PARKSIDE, SOUTH AUSTRALIA,  AU 5063
Applicant Contact BIBIANA FRANCO
Correspondent
CARE ESSENTIALS PTY LTD
SUITE 2/ 36-38 GLEN OSMOND ROAD
PARKSIDE, SOUTH AUSTRALIA,  AU 5063
Correspondent Contact BIBIANA FRANCO
Regulation Number870.5900
Classification Product Code
DWJ  
Date Received03/12/2014
Decision Date 07/25/2014
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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