510(k) K091340

THROUGH THE -PEG (TTP) JEJUNAL FEEDING TUBE KIT, MODEL M00566320,M00566330, M00566340, M00566350 by Boston Scientific Corp — Product Code FPD

Clearance Details

Decision
SESK (Substantially Equivalent (kit))
Decision Date
June 9, 2009
Date Received
May 6, 2009
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Tube, Feeding
Device Class
Class II
Regulation Number
876.5980
Review Panel
GU
Submission Type