510(k) K081942
K081942 is an FDA 510(k) premarket notification submitted by Vygon Neuro for the device "NEUROCATH AG". The FDA issued a decision of Substantially Equivalent on Aug 12, 2008. The device falls under product code JXG (Shunt, Central Nervous System And Components), a Class II device regulated under 21 CFR 882.5550.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Aug 12, 2008
- Date Received
- Jul 8, 2008
- Clearance Type
- Special
- Expedited Review
- No
- Third Party Review
- No
Device classification
- Device Name
- Shunt, Central Nervous System And Components
- Device Class
- Class II
- Regulation Number
- 882.5550
- Review Panel
- NE
- Submission Type
- 510(k)