The following data is part of a premarket notification filed by Concord Laboratories, Inc. with the FDA for Epidural Trays.
| Device ID | K842095 | 
| 510k Number | K842095 | 
| Device Name: | EPIDURAL TRAYS | 
| Classification | Anesthesia Conduction Kit | 
| Applicant | CONCORD LABORATORIES, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 | 
| Product Code | CAZ | 
| CFR Regulation Number | 868.5140 [🔎] | 
| Decision | Substantially Equivalent (SESE) | 
| Type | Traditional | 
| 3rd Party Reviewed | No | 
| Combination Product | No | 
| Date Received | 1984-05-25 | 
| Decision Date | 1984-07-03 |