510(k) K972585

AERIAL PROSTHESIS, AERIAL PROSTHESIS, MODEL DUSSELDORF, DRESDEN AERIAL PROSTHESIS, AERIAL PROSTHESIS, MODEL TUBINGEN by Heinz Kurz GmbH Medizintechnik — Product Code ETA

K972585 is an FDA 510(k) premarket notification submitted by Heinz Kurz GmbH Medizintechnik for the device "AERIAL PROSTHESIS, AERIAL PROSTHESIS, MODEL DUSSELDORF, DRESDEN AERIAL PROSTHESIS, AERIAL PROSTHESIS, MODEL TUBINGEN". The FDA issued a decision of Substantially Equivalent on August 4, 1997. The device falls under product code ETA (Replacement, Ossicular Prosthesis, Total), a Class II device regulated under 21 CFR 874.3495. Heinz Kurz GmbH Medizintechnik has at least 10 other 510(k) clearances on record.