The following data is part of a premarket notification filed by Bd Becton Dickinson Vacutainer Systems Preanalytic with the FDA for B-d Durasafe Combined Spinal Epidural (cse) Tray.
| Device ID | K954953 |
| 510k Number | K954953 |
| Device Name: | B-D DURASAFE COMBINED SPINAL EPIDURAL (CSE) TRAY |
| Classification | Anesthesia Conduction Kit |
| Applicant | BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC ONE BECTON DR. Franklin Lakes, NJ 07417 -1880 |
| Contact | Gregory W Morgan |
| Correspondent | Gregory W Morgan BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC ONE 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 | 1995-10-30 |
| Decision Date | 1996-05-20 |
| Summary: | summary |