The following data is part of a premarket notification filed by Bd Becton Dickinson Vacutainer Systems Preanalytic with the FDA for B-d Filter Needle.
| Device ID | K801343 |
| 510k Number | K801343 |
| Device Name: | B-D FILTER NEEDLE |
| Classification | Filter, Infusion Line |
| Applicant | BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | FPB |
| CFR Regulation Number | 880.5440 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1980-06-05 |
| Decision Date | 1980-06-20 |