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 Iii Pen Needle; Model 31g X 3/16.
| Device ID | K002938 |
| 510k Number | K002938 |
| Device Name: | B-D ULTRA-FINE III PEN NEEDLE; MODEL 31G X 3/16 |
| Classification | Needle, Hypodermic, Single Lumen |
| Applicant | BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC 1 BECTON DR. Franklin Lakes, NJ 07417 -1880 |
| Contact | Peter Zurlo |
| Correspondent | Peter Zurlo BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC 1 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 | 2000-09-21 |
| Decision Date | 2000-11-29 |