Device Classification Name |
stent, ureteral
|
510(k) Number |
K960148 |
Device Name |
CIRCON-SURGITEK CLASSIC DOUBLE PIGTAIL URETERAL STENT |
Applicant |
CABOT MEDICAL CORP. |
2021 CABOT BOULEVARD WEST |
LANGHORNE,
PA
19047
|
|
Applicant Contact |
TODD J POLK |
Correspondent |
CABOT MEDICAL CORP. |
2021 CABOT BOULEVARD WEST |
LANGHORNE,
PA
19047
|
|
Correspondent Contact |
TODD J POLK |
Regulation Number | 876.4620
|
Classification Product Code |
|
Date Received | 01/11/1996 |
Decision Date | 03/25/1996 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|