Device Classification Name |
stent, ureteral
|
510(k) Number |
K872353 |
Device Name |
SURGITEK INFUSION STENT SYSTEM* |
Applicant |
SURGITEK |
3037 MT. PLEASANT ST. |
RACINE,
WI
53404
|
|
Applicant Contact |
M. S WAXBERG |
Correspondent |
SURGITEK |
3037 MT. PLEASANT ST. |
RACINE,
WI
53404
|
|
Correspondent Contact |
M. S WAXBERG |
Regulation Number | 876.4620
|
Classification Product Code |
|
Date Received | 06/18/1987 |
Decision Date | 09/16/1987 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|