COCOON CONVECTIVE WARMING SYSTEM

System, Thermal Regulating

CARE ESSENTIALS PTY LTD

The following data is part of a premarket notification filed by Care Essentials Pty Ltd with the FDA for Cocoon Convective Warming System.

Pre-market Notification Details

• Device ID: K140635
• 510k Number: K140635
• Device Name: COCOON CONVECTIVE WARMING SYSTEM
• Classification: System, Thermal Regulating
• Applicant: CARE ESSENTIALS PTY LTD SUITE 2/ 36-38 GLEN OSMOND ROAD Parkside, South Australia, AU 5063
• Contact: Bibiana Franco
• Correspondent: Bibiana Franco; CARE ESSENTIALS PTY LTD SUITE 2/ 36-38 GLEN OSMOND ROAD Parkside, South Australia, AU 5063
• Product Code: DWJ
• CFR Regulation Number: 870.5900 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2014-03-12
• Decision Date: 2014-07-25
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
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