The following data is part of a premarket notification filed by Becton Dickinson Vacutainer Systems with the FDA for Vacutainer Brand Plus Tube With Edta Anticoagulant(multiple).
| Device ID | K971449 |
| 510k Number | K971449 |
| Device Name: | VACUTAINER BRAND PLUS TUBE WITH EDTA ANTICOAGULANT(MULTIPLE) |
| Classification | Tubes, Vacuum Sample, With Anticoagulant |
| Applicant | BECTON DICKINSON VACUTAINER SYSTEMS ONE BECTON DR. Franklin Lakes, NJ 07417 -1885 |
| Contact | John A Schalago |
| Correspondent | John A Schalago BECTON DICKINSON VACUTAINER SYSTEMS ONE BECTON DR. Franklin Lakes, NJ 07417 -1885 |
| Product Code | GIM |
| CFR Regulation Number | 862.1675 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-04-21 |
| Decision Date | 1997-06-17 |
| Summary: | summary |