CFR
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868.5640—Medicinal nonventilatory nebulizer (atomizer).
(a) Identification.
A medicinal nonventilatory nebulizer (atomizer) is a device that is intended to spray liquid medication in aerosol form into the air that a patient will breathe.
(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 § 868.9.
Code of Federal Regulations
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