Device Classification Name |
Endoscopic Access Overtube, Gastroenterology-Urology
|
510(k) Number |
K122649 |
Device Name |
NAVIGATOR HD URETERAL ACCESS SHEATH SET |
Applicant |
BOSTON SCIENTIFIC CORP. |
100 BOSTON SCIENTIFIC WAY |
MARLBOROUGH,
MA
01752
|
|
Applicant Contact |
HUDA YUSUF |
Correspondent |
BOSTON SCIENTIFIC CORP. |
100 BOSTON SCIENTIFIC WAY |
MARLBOROUGH,
MA
01752
|
|
Correspondent Contact |
HUDA YUSUF |
Regulation Number | 876.1500
|
Classification Product Code |
|
Date Received | 08/30/2012 |
Decision Date | 12/12/2012 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|