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: 158797
Sponsor: Ainsworth Dental Company Pty Ltd
Manufacturer: Hager & Werken GmbH & Co KG (Germany)
Date cancelled: 19 September 2012
Date of effect of the Cancellation: 22 October 2012
Reason:
The certifications made in the application to include this kind of device in the Register are not correct in relation to the classification 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
19 September 2012