Device Classification Name |
urinary drainage collection kit, for indwelling catheter
|
510(k) Number |
K883886 |
Device Name |
DOUBLE CLOSED URINARY DRAINAGE SYSTEM |
Applicant |
KNIGHT MEDICAL, INC. |
18120 AMMI TRAIL |
HOUSTON,
TX
77060
|
|
Applicant Contact |
KENNETH E CLARY |
Correspondent |
KNIGHT MEDICAL, INC. |
18120 AMMI TRAIL |
HOUSTON,
TX
77060
|
|
Correspondent Contact |
KENNETH E CLARY |
Regulation Number | 876.5250
|
Classification Product Code |
|
Date Received | 09/13/1988 |
Decision Date | 12/19/1988 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|