K954718 is an FDA 510(k) clearance for the ELLMAN NEEDLE EXTENDER/MEASURED DOSE SYRINGE. This device is classified as a Set, Anesthesia, Paracervical (Class II - Special Controls, product code HEE).
Submitted by Ellman Intl., Inc. (Sound Beach, US). The FDA issued a Cleared decision on February 29, 1996, 139 days after receiving the submission on October 13, 1995.
This device falls under the Obstetrics & Gynecology FDA review panel. Regulated under 21 CFR 884.5100.
| 510(k) Number | K954718 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 13, 1995 |
| Decision Date | February 29, 1996 |
| Days to Decision | 139 days |
| Submission Type | Traditional |
| Review Panel | Obstetrics & Gynecology (OB) |
| Summary | Statement |
| Product Code | HEE — Set, Anesthesia, Paracervical |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 884.5100 |