The following data is part of a premarket notification filed by Ellman Intl., Inc. with the FDA for Ellman Needle Extender/measured Dose Syringe.
| Device ID | K954718 |
| 510k Number | K954718 |
| Device Name: | ELLMAN NEEDLE EXTENDER/MEASURED DOSE SYRINGE |
| Classification | Set, Anesthesia, Paracervical |
| Applicant | ELLMAN INTL., INC. 30 NORTHPORT RD. Sound Beach, NY 11789 -1734 |
| Contact | Richard C Lanzillotto |
| Correspondent | Richard C Lanzillotto ELLMAN INTL., INC. 30 NORTHPORT RD. Sound Beach, NY 11789 -1734 |
| Product Code | HEE |
| CFR Regulation Number | 884.5100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-10-13 |
| Decision Date | 1996-02-29 |