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 |