(27 days)
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I apologize, but the document you provided is an FDA notification letter regarding an administrative change to a device's product code. It does not contain any information about acceptance criteria, device performance studies, or clinical trial details. Therefore, I cannot extract the requested information.
To answer your request, I would need a document that describes the device's performance characteristics and the studies conducted to demonstrate its effectiveness and safety.
§ 874.4780 Intranasal splint.
(a)
Identification. An intranasal splint is intended to minimize bleeding and edema and to prevent adhesions between the septum and the nasal cavity. It is placed in the nasal cavity after surgery or trauma. The intranasal splint is constructed from plastic, silicone, or absorbent material.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 874.9.