PEN-INJECT 2.25
Device Facts
| Record ID | K954729 |
|---|---|
| Device Name | PEN-INJECT 2.25 |
| Applicant | Scandinavian Health , Ltd. |
| Product Code | KZH · General Hospital |
| Decision Date | Jan 29, 1996 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 880.6920 |
| Device Class | Class 2 |
Regulatory Classification
Identification
A syringe needle introducer is a device that uses a spring-loaded mechanism to drive a hypodermic needle into a patient to a predetermined depth below the skin surface.