![]() |
Code of Federal Regulations (Last Updated: July 5, 2024) |
![]() |
Title 21 - Food and Drugs |
![]() |
Chapter I - Food and Drug Administration, Department of Health and Human Services |
![]() |
SubChapter H - Medical Devices |
![]() |
Part 864 - Hematology and Pathology Devices |
![]() |
Subpart J - Products Used In Establishments That Manufacture Blood and Blood Products |
§ 864.9750 - Heat-sealing device.
Latest version.
-
§ 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.
[45 FR 60650, Sept. 12, 1980, as amended at 65 FR 2311, Jan. 14, 2000]