The following data is part of a premarket notification filed by Bd Becton Dickinson Vacutainer Systems Preanalytic with the FDA for Vacutainer Brand Safety-lok Needle Holder.
| Device ID | K950432 |
| 510k Number | K950432 |
| Device Name: | VACUTAINER BRAND SAFETY-LOK NEEDLE HOLDER |
| Classification | Tubes, Vials, Systems, Serum Separators, Blood Collection |
| Applicant | BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC 1 BECTON DR. Franklin Lakes, NJ 07417 -1880 |
| Contact | Eileen Schweighardt |
| Correspondent | Eileen Schweighardt BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC 1 BECTON DR. Franklin Lakes, NJ 07417 -1880 |
| Product Code | JKA |
| CFR Regulation Number | 862.1675 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-02-02 |
| Decision Date | 1995-05-05 |