510(k) K071191
K071191 is an FDA 510(k) premarket notification submitted by Novartis Nutrition Corp. for the device "NOVARTIS COMPAT SURGICAL GASTROSTOMY JEJUNOSTOMY FEEDING TUBE KIT". The FDA issued a decision of Substantially Equivalent on July 23, 2007. The device falls under product code FPD (Tube, Feeding), a Class II device regulated under 21 CFR 876.5980. Novartis Nutrition Corp. has at least 4 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 23, 2007
- Date Received
- April 30, 2007
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- Yes
Device Classification
- Device Name
- Tube, Feeding
- Device Class
- Class II
- Regulation Number
- 876.5980
- Review Panel
- GU
- Submission Type