Device Classification Name |
tubes, gastrointestinal (and accessories)
|
510(k) Number |
K962375 |
Device Name |
MICROVASIVE BALLOON GASTROSTOMY TUBE KIT |
Applicant |
BOSTON SCIENTIFIC CORP. |
ONE BOSTON SCIENTIFIC PL. |
NATICK,
MA
01760 -1537
|
|
Applicant Contact |
LISA M QUAGLIA |
Correspondent |
BOSTON SCIENTIFIC CORP. |
ONE BOSTON SCIENTIFIC PL. |
NATICK,
MA
01760 -1537
|
|
Correspondent Contact |
LISA M QUAGLIA |
Regulation Number | 876.5980
|
Classification Product Code |
|
Date Received | 06/20/1996 |
Decision Date | 09/04/1996 |
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
|
|
|