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CFR

884.6150—Assisted reproduction micromanipulators and microinjectors.

(a) Identification. Assisted reproduction micromanipulators are devices intended to control the position of an assisted reproduction microtool. Assisted reproduction microinjectors are any device intended to control aspiration or expulsion of the contents of an assisted reproduction microtool.
(b) Classification. Class II (special controls) (design specifications, labeling requirements, and clinical testing).
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