The following data is part of a premarket notification filed by Shield Laboratories, Inc. with the FDA for Urinary Catheter Care Set.
| Device ID | K780735 |
| 510k Number | K780735 |
| Device Name: | URINARY CATHETER CARE SET |
| Classification | Tray, Catheterization, Sterile Urethral, With Or Without Catheter (kit) |
| Applicant | SHIELD 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 | 1978-05-01 |
| Decision Date | 1978-06-13 |