Device Classification Name |
Stent, Ureteral
|
510(k) Number |
K913928 |
Device Name |
SURGITEK(R) 4.5FR LUBRI-FLEX(TM) URETERAL STENT |
Applicant |
SURGITEK MEDICAL ENGINEERING CORP. |
3037 MT. PLEASANT ST. |
RACINE,
WI
53404
|
|
Applicant Contact |
WILLIAM H DUFFELL |
Correspondent |
SURGITEK MEDICAL ENGINEERING CORP. |
3037 MT. PLEASANT ST. |
RACINE,
WI
53404
|
|
Correspondent Contact |
WILLIAM H DUFFELL |
Regulation Number | 876.4620
|
Classification Product Code |
|
Date Received | 09/03/1991 |
Decision Date | 11/19/1991 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|