510(k) K113279

IDENTIUM HEAVY, IDENTIUM MEDIUM, IDENTIUM SCAN HEAVY, IDENTIUM SCAN MEDIUM, IDENTIUM SCAN LIGHT by Kettenbach GmbH & Co. KG — Product Code ELW

K113279 is an FDA 510(k) premarket notification submitted by Kettenbach GmbH & Co. KG for the device "IDENTIUM HEAVY, IDENTIUM MEDIUM, IDENTIUM SCAN HEAVY, IDENTIUM SCAN MEDIUM, IDENTIUM SCAN LIGHT". The FDA issued a decision of Substantially Equivalent on November 14, 2011. The device falls under product code ELW (Material, Impression), a Class II device regulated under 21 CFR 872.3660. Kettenbach GmbH & Co. KG has at least 10 other 510(k) clearances on record.