The following data is part of a premarket notification filed by Becton Dickinson Vacutainer Systems with the FDA for Vacutainer Brand Blood Collection Syringe.
| Device ID | K982922 |
| 510k Number | K982922 |
| Device Name: | VACUTAINER BRAND BLOOD COLLECTION SYRINGE |
| Classification | Tubes, Vials, Systems, Serum Separators, Blood Collection |
| Applicant | BECTON DICKINSON VACUTAINER SYSTEMS ONE BECTON DR. Franklin Lakes, NJ 07417 -1885 |
| Contact | Keith M Smith |
| Correspondent | Keith M Smith BECTON DICKINSON VACUTAINER SYSTEMS ONE BECTON DR. Franklin Lakes, NJ 07417 -1885 |
| Product Code | JKA |
| CFR Regulation Number | 862.1675 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-08-19 |
| Decision Date | 1998-09-22 |
| Summary: | summary |