Informal Request for ATI Records Previously Released

Organization: Health Canada

Year: 2023

Month: July

Request Number: A-2022-001398

Request Summary: Attestations to Health Canada regarding the risks of alteration to craniofacial structure, narrowing of the upper airway, compromised respiratory function, and the risk of obstructive sleep apnea posed by use of the Orthodontic Facebow/Headgear, also known as the Cervical Headgear, specifically the Item 6 attestation of compliance with Section 10 and 11(1) of the Canada Medical Device Regulations (SOR/98-282). Any attestations of the risks of these appliances under Section 10 of the Regulations. This request refers to all of the following licences for this Class II medical device: Licence No.: 34554, Licence No.: 69095, Licence No.: 78248, Licence No.: 15841, Licence No.: 87779, Licence No.: 30093, Licence No.: 99152, Licence No.: 39363, Licence No.: 107355, Licence No. 31323, and Licence No.: 95578.

Disposition: Disclosed in part

Number of pages: 197

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