The following data is part of a premarket notification filed by Concord Laboratories, Inc. with the FDA for Epidural Syringe.
| Device ID | K832778 |
| 510k Number | K832778 |
| Device Name: | EPIDURAL SYRINGE |
| Classification | Anesthesia Conduction Kit |
| Applicant | CONCORD LABORATORIES, INC. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | CAZ |
| CFR Regulation Number | 868.5140 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1983-08-16 |
| Decision Date | 1983-09-26 |