The following data is part of a premarket notification filed by Bd Becton Dickinson Vacutainer Systems Preanalytic with the FDA for Vacutainer Brand Safety-gard Phlebotomy System.
| Device ID | K945458 |
| 510k Number | K945458 |
| Device Name: | VACUTAINER BRAND SAFETY-GARD PHLEBOTOMY SYSTEM |
| Classification | Tubes, Vacuum Sample, With Anticoagulant |
| Applicant | BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC ONE BECTON DR. Franklin Lakes, NJ 07417 -1880 |
| Contact | Melanie T O'neill |
| Correspondent | Melanie T O'neill BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC ONE BECTON DR. Franklin Lakes, NJ 07417 -1880 |
| Product Code | GIM |
| CFR Regulation Number | 862.1675 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-11-07 |
| Decision Date | 1995-02-06 |