AUTOMATIC TEFLON INJECTION SYRINGE
Device Facts
| Record ID | K810284 |
|---|---|
| Device Name | AUTOMATIC TEFLON INJECTION SYRINGE |
| Applicant | R. Wolf Medical Instruments Corp. |
| Product Code | KCP · Ear, Nose, Throat |
| Decision Date | Mar 11, 1981 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 874.5220 |
| Device Class | Class 1 |
Regulatory Classification
Identification
An ear, nose, and throat drug administration device is one of a group of ear, nose, and throat devices intended specifically to administer medicinal substances to treat ear, nose, and throat disorders. These instruments include the powder blower, dropper, ear wick, manual nebulizer pump, and nasal inhaler.