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