LLP - Mask, air/oxygen (Cancelled under s. 41GN(1)(f))
Product name
LLP - Mask, air/oxygen
Sponsor
ARTG
199165
Date action takes effect
Compliance action
Medical device cancellation
Type of action
Cancelled under s. 41GN(1)(f)
Grounds for regulatory action
As the kind of medical device included in the Register was not correctly classified and the sponsor failed to provide evidence that an appropriate conformity assessment procedure has been applied to the device, the certifications made under s.41FD(c) and (f) were incorrect.