Cleared Traditional

K083780 - SUPERELELASTIC NITINOL PISTON, SUPERELASTIC NITINOL TRIMMABLE PISTON, MODEL SPL03.39/40/41/42 (DETAILS IN 510(K) ANNEX 2
(FDA 510(k) Clearance)

K083780 · Audio Technologies S.R.L. · Ear, Nose, Throat

Mar 2009

Decision

94d

Days

Class 2

Risk

K083780 is an FDA 510(k) clearance for the SUPERELELASTIC NITINOL PISTON, SUPERELASTIC NITINOL TRIMMABLE PISTON, MODEL SPL03.39/40/41/42 (DETAILS IN 510(K) ANNEX 2, a Replacement, Ossicular Prosthesis, Total (Class II — Special Controls, product code ETA), submitted by Audio Technologies S.R.L. (Piacenza, IT). The FDA issued a Cleared decision on March 23, 2009, 94 days after receiving the submission on December 19, 2008. This device falls under the Ear, Nose, Throat review panel. Regulated under 21 CFR 874.3495.

Submission Details

510(k) Number	K083780 FDA.gov
FDA Decision	Cleared SESE
Date Received	December 19, 2008
Decision Date	March 23, 2009
Days to Decision	94 days
Submission Type	Traditional
Review Panel	Ear, Nose, Throat (EN)
Summary	Summary PDF