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874.4800—Bone particle collector.
(a) Identification.
A bone particle collector is a filtering device intended to be inserted into a suction tube during the early stages of otologic surgery to collect bone particles for future use.
(b) Classification.
Class I (general controls). The device is exempt from premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 874.9.
Code of Federal Regulations
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