The following data is part of a premarket notification filed by Bd Becton Dickinson Vacutainer Systems Preanalytic with the FDA for Becton Dickinson Modified Menghini Needle.
| Device ID | K915572 |
| 510k Number | K915572 |
| Device Name: | BECTON DICKINSON MODIFIED MENGHINI NEEDLE |
| Classification | Needle, Aspiration And Injection, Reusable |
| Applicant | BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC 1 BECTON DR. Franklin Lakes, NJ 07417 -1880 |
| Contact | Russell J.arnsberger |
| Correspondent | Russell J.arnsberger BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC 1 BECTON DR. Franklin Lakes, NJ 07417 -1880 |
| Product Code | GDM |
| CFR Regulation Number | 878.4800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-12-12 |
| Decision Date | 1992-02-03 |