510(k) K973226

TUBINGEN TYMPANIC VENTILATION TUBE, TYMPANIC VENTILATION TUBES WITH ENE/S, DIABOLO TYMPANIC VENTILATION TUBE, MINIMAL T) by Heinz Kurz GmbH Medizintechnik — Product Code ETD

K973226 is an FDA 510(k) premarket notification submitted by Heinz Kurz GmbH Medizintechnik for the device "TUBINGEN TYMPANIC VENTILATION TUBE, TYMPANIC VENTILATION TUBES WITH ENE/S, DIABOLO TYMPANIC VENTILATION TUBE, MINIMAL T)". The FDA issued a decision of Substantially Equivalent on November 4, 1997. The device falls under product code ETD (Tube, Tympanostomy), a Class II device regulated under 21 CFR 874.3880. Heinz Kurz GmbH Medizintechnik has at least 10 other 510(k) clearances on record.