510(k) K091340

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

K091340 is an FDA 510(k) premarket notification submitted by Boston Scientific Corp for the device "THROUGH THE -PEG (TTP) JEJUNAL FEEDING TUBE KIT, MODEL M00566320,M00566330, M00566340, M00566350". The FDA issued a decision of Substantially Equivalent (kit) on June 9, 2009. The device falls under product code FPD (Tube, Feeding), a Class II device regulated under 21 CFR 876.5980. Boston Scientific Corp has at least 10 other 510(k) clearances on record.

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