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e-CFR data is current as of March 2, 2021

Title 21Chapter ISubchapter HPart 872Subpart G → §872.6770


Title 21: Food and Drugs
PART 872—DENTAL DEVICES
Subpart G—Miscellaneous Devices


§872.6770   Cartridge syringe.

(a) Identification. A cartridge syringe is a device intended to inject anesthetic agents subcutaneously or intramuscularly. The device consists of a metal syringe body into which a disposable, previously filled, glass carpule (a cylindrical cartridge) containing anesthetic is placed. After attaching a needle to the syringe body and activating the carpule by partially inserting the plunger on the syringe, the device is used to administer an injection to the patient.

(b) Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in §872.9.

[52 FR 30097, Aug. 12, 1987, as amended at 84 FR 71813, Dec. 30, 2019]

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