(a)Identification. A cement ventilation tube is a tube-like device usually made of plastic intended to be inserted into a surgical cavity to allow the release of air or fluid from the cavity as it is being filled with bone cement (888.3027).
(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 888.9.
[52 FR 33702, Sept. 4, 1987, as amended at 53 FR 52954, Dec. 29, 1988; 59 FR 63014, Dec. 7, 1994; 66 FR 38815, July 25, 2001]