The following data is part of a premarket notification filed by Concord Laboratories, Inc. with the FDA for Tray, Catheterization W/o Catheter.
| Device ID | K760127 |
| 510k Number | K760127 |
| Device Name: | TRAY, CATHETERIZATION W/O CATHETER |
| Classification | Tray, Catheterization, Sterile Urethral, With Or Without Catheter (kit) |
| Applicant | CONCORD LABORATORIES, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | FCM |
| CFR Regulation Number | 876.5130 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1976-06-28 |
| Decision Date | 1976-10-07 |