Device Classification Name |
Stent, Ureteral
|
510(k) Number |
K880660 |
Device Name |
SURGITEK SUPER DOUBLE J URETERAL STENT KIT |
Applicant |
SURGITEK |
3037 MT. PLEASANT ST. |
RACINE,
WI
53404
|
|
Applicant Contact |
WAXBERG |
Correspondent |
SURGITEK |
3037 MT. PLEASANT ST. |
RACINE,
WI
53404
|
|
Correspondent Contact |
WAXBERG |
Regulation Number | 876.4620
|
Classification Product Code |
|
Date Received | 02/17/1988 |
Decision Date | 04/14/1988 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|