510(k) K853366

H-H UNITIZED STANDARD SHUNT/RESERVOIR SHUNT by Holter-Hausner Intl. — Product Code JXG

K853366 is an FDA 510(k) premarket notification submitted by Holter-Hausner Intl. for the device "H-H UNITIZED STANDARD SHUNT/RESERVOIR SHUNT". The FDA issued a decision of Substantially Equivalent on September 11, 1985. The device falls under product code JXG (Shunt, Central Nervous System And Components), a Class II device regulated under 21 CFR 882.5550. Holter-Hausner Intl. has at least 10 other 510(k) clearances on record.