Device Classification Name |
Dilator, Catheter, Ureteral
|
510(k) Number |
K953004 |
Device Name |
DILATATION CATHETER, BALLOON |
Applicant |
BOSTON SCIENTIFIC CORP. |
ONE BOSTON SCIENTIFIC PL. |
NATICK,
MA
01760 -1537
|
|
Applicant Contact |
Lorraine M Hanley |
Correspondent |
BOSTON SCIENTIFIC CORP. |
ONE BOSTON SCIENTIFIC PL. |
NATICK,
MA
01760 -1537
|
|
Correspondent Contact |
Lorraine M Hanley |
Regulation Number | 876.5470
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 06/28/1995 |
Decision Date | 09/13/1995 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|