Medical Device Manufacturer · AU , Parkside, South Australia

Care Essentials Pty, Ltd.

4 submissions · 4 cleared · Since 2014
4
Total
4
Cleared
0
Denied

Care Essentials Pty, Ltd. — FDA 510(k) Submissions

Care Essentials Pty, Ltd. has submitted 4 FDA 510(k) premarket notifications since 2014, of which 4 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include System, Thermal Regulating, Wrap, Sterilization . Use the specialty filter in the sidebar to narrow results.

4 devices
1–4 of 4
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All4 Cardiovascular 3 General Hospital 1