510(k) K970658
K970658 is an FDA 510(k) premarket notification submitted by Integra Neurocare, LLC for the device "LUMBAR DRAINAGE ACCESSORY KIT". The FDA issued a decision of Substantially Equivalent on May 19, 1997. The device falls under product code JXG (Shunt, Central Nervous System And Components), a Class II device regulated under 21 CFR 882.5550. Integra Neurocare, LLC has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 19, 1997
- Date Received
- February 21, 1997
- Clearance Type
- Traditional
- 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