The following data is part of a premarket notification filed by Concord Laboratories, Inc. with the FDA for Urethral Tray W/out Cahteter, 7650.
| Device ID | K771104 |
| 510k Number | K771104 |
| Device Name: | URETHRAL TRAY W/OUT CAHTETER, 7650 |
| 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 | 1977-06-20 |
| Decision Date | 1977-06-24 |