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Mask, air/oxygen (Cancelled from the ARTG under s.41GN(1)(b)(c) and (f))
Product name
Mask, air/oxygen
Sponsor
ARTG details
- 210899
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, failed to demonstrate the application of the appropriate conformity assessment procedures for devices of the kind and failed to provide sufficient information to demonstrate compliance with the Essential Principles.