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, Irina Tsyganova, 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: Cannula, dental, suction, reusable
ARTG number: 158802
Sponsor: Ainsworth Dental Company Pty Ltd
Manufacturer: Hager & Werken GmbH & Co KG (Germany)
Date cancelled: 7 May 2013
Date of effect of cancellation: 7 June 2013
Reasons:
The certifications made in the application to include this kind of device in the Register are not correct in relation to the classification of this kind of device, the compliance of the device with the Essential Principles and the Conformity Assessment Procedures applied to this kind of device.
(Signed by)
Irina Tsyganova
Delegate of the Secretary to the Department of Health and Ageing
7 May 2013