510(k) K090559
K090559 is an FDA 510(k) premarket notification submitted by Footprint Medical for the device "FOOTPRINT MEDICAL SILICONE FEEDING TUBE". The FDA issued a decision of Substantially Equivalent on May 4, 2009. The device falls under product code KNT (Tubes, Gastrointestinal (And Accessories)), a Class II device regulated under 21 CFR 876.5980. Footprint Medical has at least 9 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 4, 2009
- Date Received
- March 2, 2009
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Tubes, Gastrointestinal (And Accessories)
- Device Class
- Class II
- Regulation Number
- 876.5980
- Review Panel
- GU
- Submission Type