Device Classification Name |
accessories, catheter, g-u
|
510(k) Number |
K942205 |
Device Name |
ZEBRA UROLOGICAL GUIDEWIRE |
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 | 876.5130
|
Classification Product Code |
|
Date Received | 05/05/1994 |
Decision Date | 07/07/1994 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|