The following data is part of a premarket notification filed by Bd with the FDA for Modification To: Bd Durasafe Plus Epidural Lock Cse Needle Set/kit.
| Device ID | K012584 |
| 510k Number | K012584 |
| Device Name: | MODIFICATION TO: BD DURASAFE PLUS EPIDURAL LOCK CSE NEEDLE SET/KIT |
| Classification | Anesthesia Conduction Kit |
| Applicant | BD 1 BECTON DR. MC 226 Franklin Lakes, NJ 07417 |
| Contact | Pasquale Amato |
| Correspondent | Pasquale Amato BD 1 BECTON DR. MC 226 Franklin Lakes, NJ 07417 |
| Product Code | CAZ |
| CFR Regulation Number | 868.5140 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-08-10 |
| Decision Date | 2001-09-06 |
| Summary: | summary |