Device Classification Name |
Ligator, Hemorrhoidal
|
510(k) Number |
K020824 |
Device Name |
SPEEDBAND SUPERVIEW SUPER 7, INJECTION SPEEDBAND SUPERVIEW SUPER 7, MODELS 4205 AND 4238 |
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 | 876.4400
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 03/14/2002 |
Decision Date | 04/12/2002 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|