Device Classification Name |
Tube, Feeding
|
510(k) Number |
K091340 |
Device Name |
THROUGH THE -PEG (TTP) JEJUNAL FEEDING TUBE KIT, MODEL M00566320,M00566330, M00566340, M00566350 |
Applicant |
BOSTON SCIENTIFIC CORP. |
100 BOSTON SCIENTIFIC WAY |
MARLBOROUGH,
MA
01752
|
|
Applicant Contact |
Marybeth Gamber |
Correspondent |
BOSTON SCIENTIFIC CORP. |
100 BOSTON SCIENTIFIC WAY |
MARLBOROUGH,
MA
01752
|
|
Correspondent Contact |
Marybeth Gamber |
Regulation Number | 876.5980
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 05/06/2009 |
Decision Date | 06/09/2009 |
Decision |
Substantially Equivalent - Kit
(SESK) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|