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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Replacement, Ossicular Prosthesis, Total
510(k) Number K083780
Device Name SUPERELELASTIC NITINOL PISTON, SUPERELASTIC NITINOL TRIMMABLE PISTON, MODEL SPL03.39/40/41/42 (DETAILS IN 510(K) ANNEX 2
Applicant
Audio Technologies S.R.L.
Via Vallera, 42
Piacenza,  IT I-29100
Applicant Contact FRANCO BEONI
Correspondent
Audio Technologies S.R.L.
Via Vallera, 42
Piacenza,  IT I-29100
Correspondent Contact FRANCO BEONI
Regulation Number874.3495
Classification Product Code
ETA  
Subsequent Product Code
ETB  
Date Received12/19/2008
Decision Date 03/23/2009
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ear Nose & Throat
510k Review Panel Ear Nose & Throat
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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