The following data is part of a premarket notification filed by Bd Becton Dickinson Vacutainer Systems Preanalytic with the FDA for B-d Ultra Fine Ii, Micro Fine + Short Needle Insulin Syringe.
| Device ID | K955235 |
| 510k Number | K955235 |
| Device Name: | B-D ULTRA FINE II, MICRO FINE + SHORT NEEDLE INSULIN SYRINGE |
| Classification | Needle, Hypodermic, Single Lumen |
| Applicant | BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC ONE BECTON DR. Franklin Lakes, NJ 07417 -1880 |
| Contact | Petyer Zurlo |
| Correspondent | Petyer Zurlo BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC ONE BECTON DR. Franklin Lakes, NJ 07417 -1880 |
| Product Code | FMI |
| CFR Regulation Number | 880.5570 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-11-14 |
| Decision Date | 1996-02-12 |