ELLMAN NEEDLE EXTENDER/MEASURED DOSE SYRINGE
Device Facts
| Record ID | K954718 |
|---|---|
| Device Name | ELLMAN NEEDLE EXTENDER/MEASURED DOSE SYRINGE |
| Applicant | Ellman Intl., Inc. |
| Product Code | HEE · Obstetrics/Gynecology |
| Decision Date | Feb 29, 1996 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 884.5100 |
| Device Class | Class 2 |
Regulatory Classification
Identification
An obstetric anesthesia set is an assembly of antiseptic solution, needles, needle guides, syringes, and other accessories, intended for use with an anesthetic drug. This device is used to administer regional blocks (e.g., paracervical, uterosacral, and pudendal) that may be used during labor, delivery, or both.
