21 C.F.R. § 864.9750 Heat-sealing device.
Title 21 - Food and Drugs
(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. [45 FR 60650, Sept. 12, 1980, as amended at 65 FR 2311, Jan. 14, 2000]
Title 21: Food and Drugs
PART 864—HEMATOLOGY AND PATHOLOGY DEVICES
Subpart J—Products Used In Establishments That Manufacture Blood and Blood Products
§ 864.9750 Heat-sealing device.
