Device Classification Name |
Stent, Colonic, Metallic, Expandable
|
510(k) Number |
K030769 |
Device Name |
ULTRAFLEX PRECISION COLONIC STENT |
Applicant |
BOSTON SCIENTIFIC CORP. |
ONE BOSTON SCIENTIFIC PLACE |
NATICK,
MA
01760 -1537
|
|
Applicant Contact |
KATHLEEN MORAHAN |
Correspondent |
BOSTON SCIENTIFIC CORP. |
ONE BOSTON SCIENTIFIC PLACE |
NATICK,
MA
01760 -1537
|
|
Correspondent Contact |
KATHLEEN MORAHAN |
Regulation Number | 878.3610
|
Classification Product Code |
|
Date Received | 03/11/2003 |
Decision Date | 07/14/2003 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General & Plastic Surgery
|
510k Review Panel |
Gastroenterology/Urology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|