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Nomenclature changes to part 864 appear at 73 FR 35341, June 23, 2008.
(a) Identification. A vacuum-assisted blood collection system is a device intended for medical purposes that uses a vacuum to draw blood for subsequent reinfusion.
(b) Classification. Class I (general controls). The manual device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 864.9.
[45 FR 60639, Sept. 12, 1980, as amended at 65 FR 2310, Jan. 14, 2000]