Device Classification Name |
device, urine flow rate measuring, non-electrical, disposable
|
510(k) Number |
K883274 |
Device Name |
SURGITEK (R) UROFLOW SYSTEM |
Applicant |
MEDICAL ENGINEERING CORP. |
3037 MT. PLEASANT ST. |
RACINE,
WI
53404
|
|
Applicant Contact |
BETTY A LOCK |
Correspondent |
MEDICAL ENGINEERING CORP. |
3037 MT. PLEASANT ST. |
RACINE,
WI
53404
|
|
Correspondent Contact |
BETTY A LOCK |
Regulation Number | 876.1800
|
Classification Product Code |
|
Date Received | 08/03/1988 |
Decision Date | 02/08/1989 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|