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Electronic Code of Federal Regulations

e-CFR data is current as of November 15, 2019

Title 21Chapter ISubchapter HPart 864Subpart J → §864.9750


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.

(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]

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