510(k) K902783

PS MEDICAL DELTA CSF-FLOW CONTROL VALVE by Pudenz-Schulte Medical Research Corp. — Product Code JXG

K902783 is an FDA 510(k) premarket notification submitted by Pudenz-Schulte Medical Research Corp. for the device "PS MEDICAL DELTA CSF-FLOW CONTROL VALVE". The FDA issued a decision of Substantially Equivalent on August 8, 1990. 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.