The following data is part of a premarket notification filed by Bd Becton Dickinson Vacutainer Systems Preanalytic with the FDA for Becton Dickinson Blunt Plastic Cannula.
| Device ID | K964654 |
| 510k Number | K964654 |
| Device Name: | BECTON DICKINSON BLUNT PLASTIC CANNULA |
| Classification | Needle, Hypodermic, Single Lumen |
| Applicant | BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC 1 BECTON DRIVE, BLDG 2, MAIL CODE 226 Franklin Lakes, NJ 07417 |
| Contact | Gregory W Morgan |
| Correspondent | Gregory W Morgan BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC 1 BECTON DRIVE, BLDG 2, MAIL CODE 226 Franklin Lakes, NJ 07417 |
| Product Code | FMI |
| CFR Regulation Number | 880.5570 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-11-20 |
| Decision Date | 1997-04-02 |
| Summary: | summary |