The following data is part of a premarket notification filed by Knight Medical, Inc. with the FDA for Double Closed Urinary Drainage System.
| Device ID | K883886 |
| 510k Number | K883886 |
| Device Name: | DOUBLE CLOSED URINARY DRAINAGE SYSTEM |
| Classification | Urinary Drainage Collection Kit, For Indwelling Catheter |
| Applicant | KNIGHT MEDICAL, INC. 18120 AMMI TRAIL Houston, TX 77060 |
| Contact | Kenneth E Clary |
| Correspondent | Kenneth E Clary KNIGHT MEDICAL, INC. 18120 AMMI TRAIL Houston, TX 77060 |
| Product Code | FCN |
| CFR Regulation Number | 876.5250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-09-13 |
| Decision Date | 1988-12-19 |