Device Classification Name |
dilator, catheter, ureteral
|
510(k) Number |
K903813 |
Device Name |
URETERAL BALLOON DILATATION CATHETER |
Applicant |
BOSTON SCIENTIFIC CORP. |
2710 ORCHARD PKWY. |
SAN JOSE,
CA
95134
|
|
Applicant Contact |
JEANNE M LESNIAK |
Correspondent |
BOSTON SCIENTIFIC CORP. |
2710 ORCHARD PKWY. |
SAN JOSE,
CA
95134
|
|
Correspondent Contact |
JEANNE M LESNIAK |
Regulation Number | 876.5470
|
Classification Product Code |
|
Date Received | 08/20/1990 |
Decision Date | 11/07/1990 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|