510(k) K950913

PERFECT, ENT SET, PRAKTIKANT, DE LUXE by Rudolf Riester GmbH & Co. KG — Product Code ERA

K950913 is an FDA 510(k) premarket notification submitted by Rudolf Riester GmbH & Co. KG for the device "PERFECT, ENT SET, PRAKTIKANT, DE LUXE". The FDA issued a decision of Substantially Equivalent on May 12, 1995. The device falls under product code ERA (Otoscope), a Class I device regulated under 21 CFR 874.4770. Rudolf Riester GmbH & Co. KG has at least 10 other 510(k) clearances on record.