Device Classification Name |
endoscopic irrigation/suction system
|
510(k) Number |
K130909 |
Device Name |
GATEWAY ADVANAGE Y-ADAPTER |
Applicant |
BOSTON SCIENTIFIC CORP. |
100 BOSTON SCIENTIFIC WAY |
MARLBOROUGH,
MA
01752
|
|
Applicant Contact |
CHRISTINE SHOEMAKER |
Correspondent |
BOSTON SCIENTIFIC CORP. |
100 BOSTON SCIENTIFIC WAY |
MARLBOROUGH,
MA
01752
|
|
Correspondent Contact |
CHRISTINE SHOEMAKER |
Regulation Number | 876.1500
|
Classification Product Code |
|
Date Received | 04/01/2013 |
Decision Date | 05/16/2013 |
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
|