510(k) K091340
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