510(k) K083780

SUPERELELASTIC NITINOL PISTON, SUPERELASTIC NITINOL TRIMMABLE PISTON, MODEL SPL03.39/40/41/42 (DETAILS IN 510(K) ANNEX 2 by Audio Technologies S.R.L. — Product Code ETA

K083780 is an FDA 510(k) premarket notification submitted by Audio Technologies S.R.L. for the device "SUPERELELASTIC NITINOL PISTON, SUPERELASTIC NITINOL TRIMMABLE PISTON, MODEL SPL03.39/40/41/42 (DETAILS IN 510(K) ANNEX 2". The FDA issued a decision of Substantially Equivalent on March 23, 2009. The device falls under product code ETA (Replacement, Ossicular Prosthesis, Total), a Class II device regulated under 21 CFR 874.3495. Audio Technologies S.R.L. has at least 1 other 510(k) clearance on record.