510(k) K834593

ONE-PIECE SHUNT by American Heyer Schulte — Product Code JXG

K834593 is an FDA 510(k) premarket notification submitted by American Heyer Schulte for the device "ONE-PIECE SHUNT". The FDA issued a decision of Substantially Equivalent on April 3, 1984. The device falls under product code JXG (Shunt, Central Nervous System And Components), a Class II device regulated under 21 CFR 882.5550. American Heyer Schulte has at least 10 other 510(k) clearances on record.