Device Classification Name |
laparoscope, general & plastic surgery
|
510(k) Number |
K041827 |
Device Name |
DUALFLEX RX ERCP CANNULA, MODELS 4681, 4682 |
Applicant |
BOSTON SCIENTIFIC CORP. |
ONE BOSTON SCIENTIFIC PL. |
NATICK,
MA
01760 -1537
|
|
Applicant Contact |
PAIGE SWEENEY |
Correspondent |
BOSTON SCIENTIFIC CORP. |
ONE BOSTON SCIENTIFIC PL. |
NATICK,
MA
01760 -1537
|
|
Correspondent Contact |
PAIGE SWEENEY |
Regulation Number | 876.1500
|
Classification Product Code |
|
Date Received | 07/07/2004 |
Decision Date | 08/06/2004 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
General & Plastic Surgery
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|