THE EXPANDACELL EAR PACK
Device Facts
| Record ID | K940133 |
|---|---|
| Device Name | THE EXPANDACELL EAR PACK |
| Applicant | Denver Splint Co. |
| Product Code | LRD · Ear, Nose, Throat |
| Decision Date | May 23, 1994 |
| 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.
