Device Classification Name |
dilator, catheter, ureteral
|
510(k) Number |
K935379 |
Device Name |
UROLOGICAL BALLOON DILATATION CATHETER |
Applicant |
BOSTON SCIENTIFIC CORP. |
480 PLEASANT ST. |
WATERTOWN,
MA
02472 -2407
|
|
Applicant Contact |
Lorraine M Hanley |
Correspondent |
BOSTON SCIENTIFIC CORP. |
480 PLEASANT ST. |
WATERTOWN,
MA
02472 -2407
|
|
Correspondent Contact |
Lorraine M Hanley |
Regulation Number | 876.5470
|
Classification Product Code |
|
Date Received | 11/09/1993 |
Decision Date | 02/14/1994 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|