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 |