Device Classification Name |
catheter, ureteral, gastro-urology
|
510(k) Number |
K930483 |
Device Name |
URETERAL CATHETER |
Applicant |
SURGITEK |
3037 MT. PLEASANT ST. |
RACINE,
WI
53404
|
|
Applicant Contact |
BRIAN KUNST |
Correspondent |
SURGITEK |
3037 MT. PLEASANT ST. |
RACINE,
WI
53404
|
|
Correspondent Contact |
BRIAN KUNST |
Regulation Number | 876.5130
|
Classification Product Code |
|
Date Received | 01/29/1993 |
Decision Date | 07/16/1993 |
Decision |
Substantially Equivalent - Kit
(SESK) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|