Device Classification Name |
Unit, Electrosurgical, Endoscopic (With Or Without Accessories)
|
510(k) Number |
K110887 |
Device Name |
INJECTION GOLD PROBE BIPOLAR ELECTROHEMOSTASIS CATHETER |
Applicant |
Boston Scientific Corporation |
100 BOSTON SCIENTIFIC WAY |
MARLBOROUGH,
MA
01752
|
|
Applicant Contact |
ASHLEY PYLE |
Correspondent |
Boston Scientific Corporation |
100 BOSTON SCIENTIFIC WAY |
MARLBOROUGH,
MA
01752
|
|
Correspondent Contact |
ASHLEY PYLE |
Regulation Number | 876.4300
|
Classification Product Code |
|
Date Received | 03/30/2011 |
Decision Date | 04/14/2011 |
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
|
|
|