Title 21

SECTION 884.6140

884.6140 Assisted reproduction micropipette fabrication instruments.

§ 884.6140 Assisted reproduction micropipette fabrication instruments.

(a) Identification. Assisted reproduction micropipette fabrication devices are instruments intended to pull, bevel, or forge a micropipette or needle for intracytoplasmic sperm injection (ICSI), in vitro fertilization (IVF) or other similar assisted reproduction procedures.

(b) Classification. Class II (special controls) (design specifications, labeling requirements, and clinical testing).

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