510(k) K972994

EXTERNAL CSF DRAINAGE MANAGEMENT SYSTEMS by Integra Neurocare, LLC — Product Code JXG

K972994 is an FDA 510(k) premarket notification submitted by Integra Neurocare, LLC for the device "EXTERNAL CSF DRAINAGE MANAGEMENT SYSTEMS". The FDA issued a decision of Substantially Equivalent on November 3, 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.