The following data is part of a premarket notification filed by Bd Becton Dickinson Vacutainer Systems Preanalytic with the FDA for Becton Dickinson Precision Cut(tm) Coaxial Introducer Needle With Depth Stop.
| Device ID | K945813 |
| 510k Number | K945813 |
| Device Name: | BECTON DICKINSON PRECISION CUT(TM) COAXIAL INTRODUCER NEEDLE WITH DEPTH STOP |
| Classification | Biopsy Needle |
| Applicant | BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC 1 BECTON DR. Franklin Lakes, NJ 07417 -1880 |
| Contact | Gregory Morgan |
| Correspondent | Gregory Morgan BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC 1 BECTON DR. Franklin Lakes, NJ 07417 -1880 |
| Product Code | FCG |
| CFR Regulation Number | 876.1075 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-11-28 |
| Decision Date | 1995-02-07 |