Device Classification Name |
biopsy needle
|
510(k) Number |
K040893 |
Device Name |
EASY CORE BIOPSY SYSTEM |
Applicant |
BOSTON SCIENTIFIC CORP. |
ONE BOSTON SCIENTIFIC PL. |
NATICK,
MA
01760 -1537
|
|
Applicant Contact |
CHRISTINE M CAMERON |
Correspondent |
BOSTON SCIENTIFIC CORP. |
ONE BOSTON SCIENTIFIC PL. |
NATICK,
MA
01760 -1537
|
|
Correspondent Contact |
CHRISTINE M CAMERON |
Regulation Number | 876.1075
|
Classification Product Code |
|
Date Received | 04/06/2004 |
Decision Date | 05/06/2004 |
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
|
Recalls |
CDRH Recalls
|
|
|