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Mask, air/oxygen (Cancelled from the ARTG under s.41GN(1)(b)(c) and (f))

Product name
Mask, air/oxygen
Date action takes effect
Compliance action
Medical device cancellation
Type of action
Cancelled from the ARTG under s.41GN(1)(b)(c) and (f)
Grounds for regulatory action
The sponsor failed to provide information in response to a Notice issued under section 41JA. Further as the sponsor did not provide sufficient information to substantiate compliance of the kind of device with the essential principles and the application of the appropriate conformity assessment procedures to the device, the sponsor failed to demonstrate that all matters certified under section 41FD in relation to the application for inclusion of the device in the ARTG were correct, in a material particular, and that the sponsor complies with the conditions of inclusion of the kind of device in the ARTG.

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