510(k) K914492
K914492 is an FDA 510(k) premarket notification submitted by Sandoz Nutrition for the device "GASTROINTESTINAL TUBE AND ACCESSORIES". The FDA issued a decision of Substantially Equivalent - Kit on Feb 25, 1992. The device falls under product code FPD (Tube, Feeding), a Class II device regulated under 21 CFR 876.5980. Sandoz Nutrition has 19 other 510(k) clearances on record.
Clearance details
- Decision
- SESK (Substantially Equivalent - Kit)
- Decision Date
- Feb 25, 1992
- Date Received
- Oct 8, 1991
- Clearance Type
- Traditional
- 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
- 510(k)