Device Classification Name |
unit, electrosurgical, endoscopic (with or without accessories)
|
510(k) Number |
K122203 |
Device Name |
TRUETOME |
Applicant |
BOSTON SCIENTIFIC CORP. |
100 BOSTON SCIENTIFIC WAY |
MARLBOROUGH,
MA
01752
|
|
Applicant Contact |
LAURIE PANNELLA |
Correspondent |
BOSTON SCIENTIFIC CORP. |
100 BOSTON SCIENTIFIC WAY |
MARLBOROUGH,
MA
01752
|
|
Correspondent Contact |
LAURIE PANNELLA |
Regulation Number | 876.4300
|
Classification Product Code |
|
Date Received | 07/25/2012 |
Decision Date | 08/17/2012 |
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
|
|
|