Regulatory Text
21 C.F.R. § 874.4780 — Intranasal splint.
§ 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. [64 FR 10949, Mar. 8, 1999]
Source: ecfr.gov · govinfo.gov — public domain
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21 C.F.R. § 874.4780
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The regulatory text of 21 C.F.R. § 874.4780 is reproduced from the official Code of Federal Regulations as published by the Office of the Federal Register and the National Archives and Records Administration.
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21 C.F.R. — public domain
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