CFR > Title 21 - Food and Drugs > CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES > SUBCHAPTER H—MEDICAL DEVICES (parts 800 to 898) > PART 864—HEMATOLOGY AND PATHOLOGY DEVICES > SUBPART J—Products Used In Establishments That Manufacture Blood and Blood Products (§864.9050 to §864.9875) > 864.9750—Heat-sealing device.

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.

Code of Federal Regulations

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