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Title 21Chapter ISubchapter HPart 864Subpart J → §864.9125


Title 21: Food and Drugs
PART 864—HEMATOLOGY AND PATHOLOGY DEVICES
Subpart J—Products Used In Establishments That Manufacture Blood and Blood Products


§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.

[45 FR 60639, Sept. 12, 1980, as amended at 65 FR 2310, Jan. 14, 2000]

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