ASTRA LIGHTWEIGHT STAINLESS STEEL SELF ASPIR/SYRIN
Device Facts
| Record ID | K851903 |
|---|---|
| Device Name | ASTRA LIGHTWEIGHT STAINLESS STEEL SELF ASPIR/SYRIN |
| Applicant | Astra Pharmaceutical Products, Inc. |
| Product Code | EJI · Dental |
| Decision Date | Jul 2, 1985 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 872.6770 |
| Device Class | Class 2 |
Regulatory Classification
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.
Special Controls
*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.
