PUBLICATION OF CANCELLATION OF ENTRIES FOR KINDS OF MEDICAL DEVICES
FROM THE AUSTRALIAN REGISTER OF THERAPEUTIC GOODS
SECTION 41GP OF THE THERAPEUTIC GOODS ACT 1989
I, Rodolfo Ferrari, delegate of the Secretary to the Department of Health and Ageing for the purposes of section 41GP of the Therapeutic Goods Act 1989 (the Act), hereby publish particulars of the cancellation of the following entry of a kind of medical device from the Australian Register of Therapeutic Goods under subsection 41GN(1)(f) of the Act:
ARTG entry of a kind of medical device: Mask, air/oxygen [35171]
ARTG number: 199165
Sponsor: SP Services (Aus) LLP
Manufacturer: SP Services UK Ltd (United Kingdom)
Date of Decision: 4 July 2013
Date of Effect of Cancellation: 5 August 2013
Reason:
Cancelled under section 41GN (1)(f) of the Act. The certifications made in the application to include this kind of device in the Register are not correct in relation to the classification of the device under section 41FD(c) of the Act and the Conformity Assessment Procedures applied to the device under section 41FD(e) of the Act.
(signed by)
Rodolfo Ferrari
Delegate of the Secretary to the Department of Health and Ageing
4 July 2013