Device Classification Name |
tube, drainage, suprapubic
|
510(k) Number |
K944290 |
Device Name |
CATHETERS, BILIARY CATHETERS, UROLOGICAL |
Applicant |
BOSTON SCIENTIFIC CORP. |
780 BROOKSIDE DR. |
SPENCER,
IN
47460
|
|
Applicant Contact |
LORRAIN M HANLEY |
Correspondent |
BOSTON SCIENTIFIC CORP. |
780 BROOKSIDE DR. |
SPENCER,
IN
47460
|
|
Correspondent Contact |
LORRAIN M HANLEY |
Regulation Number | 876.5090
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 09/02/1994 |
Decision Date | 12/08/1994 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|