The following data is part of a premarket notification filed by Bd Becton Dickinson Vacutainer Systems Preanalytic with the FDA for B-d Durasafe)tm) Variable Extension Combined Spinal Epidural *cse) Needle Set/kit.
| Device ID | K945497 |
| 510k Number | K945497 |
| Device Name: | B-D DURASAFE)TM) VARIABLE EXTENSION COMBINED SPINAL EPIDURAL *CSE) NEEDLE SET/KIT |
| Classification | Anesthesia Conduction Kit |
| Applicant | BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC 1 BECTON DR. Franklin Lakes, NJ 07417 -1880 |
| Contact | Gregopry W Morgan |
| Correspondent | Gregopry W Morgan BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC 1 BECTON DR. Franklin Lakes, NJ 07417 -1880 |
| Product Code | CAZ |
| CFR Regulation Number | 868.5140 [🔎] |
| Decision | Substantially Equivalent - Kit (SESK) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-11-08 |
| Decision Date | 1995-02-13 |