Device Classification Name |
endoscopic access overtube, gastroenterology-urology
|
510(k) Number |
K140323 |
Device Name |
NAVIGATOR HD URETERAL ACCESS SHEATH SETS |
Applicant |
BOSTON SCIENTIFIC |
100 BOSTON SCIENTIFIC WAY |
MARLBOROUGH,
MA
01752
|
|
Applicant Contact |
NICHOLE RIEK |
Correspondent |
BOSTON SCIENTIFIC |
100 BOSTON SCIENTIFIC WAY |
MARLBOROUGH,
MA
01752
|
|
Correspondent Contact |
NICHOLE RIEK |
Regulation Number | 876.1500
|
Classification Product Code |
|
Date Received | 02/10/2014 |
Decision Date | 03/07/2014 |
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
|
|
|