21 C.F.R. § 864.9750

Current through October 31, 2024
Section 864.9750 - Heat-sealing device
(a)Identification. A heat-sealing device is a device intended for medical purposes that uses heat to seal plastic bags containing blood or blood components.
(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 § 864.9 .

21 C.F.R. §864.9750

45 FR 60650, Sept. 12, 1980, as amended at 65 FR 2311 , Jan. 14, 2000