510(k) K913412

PS MEDICAL CSF-ACCESS DEVICE by Pudenz-Schulte Medical Research Corp. — Product Code JXG

K913412 is an FDA 510(k) premarket notification submitted by Pudenz-Schulte Medical Research Corp. for the device "PS MEDICAL CSF-ACCESS DEVICE". The FDA issued a decision of Substantially Equivalent on March 30, 1993. 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.