CFR
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864.9125—Vacuum-assisted blood collection system.
(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.
Code of Federal Regulations
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