510(k) K060944
K060944 is an FDA 510(k) premarket notification submitted by Vygon Corp. for the device "NUTRISAFE 2". The FDA issued a decision of Substantially Equivalent on September 15, 2006. The device falls under product code FPD (Tube, Feeding), a Class II device regulated under 21 CFR 876.5980. Vygon Corp. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 15, 2006
- Date Received
- April 6, 2006
- 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