MIMIMED SIL-SERTER INFUSION SET INSERTION SYSTEM, MODEL 385
Device Facts
| Record ID | K010377 |
|---|---|
| Device Name | MIMIMED SIL-SERTER INFUSION SET INSERTION SYSTEM, MODEL 385 |
| Applicant | Minimed, Inc. |
| Product Code | KZH · General Hospital |
| Decision Date | Apr 5, 2001 |
| 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.