510(k) K951258

PS MEDICAL BIOGLIDE CSF-FLOW CONTROL SHUNT KIT by Pudenz-Schulte Medical Research Corp. — Product Code JXG

K951258 is an FDA 510(k) premarket notification submitted by Pudenz-Schulte Medical Research Corp. for the device "PS MEDICAL BIOGLIDE CSF-FLOW CONTROL SHUNT KIT". The FDA issued a decision of Substantially Equivalent on September 18, 1995. The device falls under product code JXG (Shunt, Central Nervous System And Components), a Class II device regulated under 21 CFR 882.5550. Pudenz-Schulte Medical Research Corp. has at least 10 other 510(k) clearances on record.