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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 K972585
Device Name AERIAL PROSTHESIS, AERIAL PROSTHESIS, MODEL DUSSELDORF, DRESDEN AERIAL PROSTHESIS, AERIAL PROSTHESIS, MODEL TUBINGEN
Applicant
Heinz Kurz GmbH Medizintechnik
Tubinger Strasse 3
Dusslingen,  DE D-72144
Applicant Contact DAGMAR S MASER
Correspondent
Heinz Kurz GmbH Medizintechnik
Tubinger Strasse 3
Dusslingen,  DE D-72144
Correspondent Contact DAGMAR S MASER
Regulation Number874.3495
Classification Product Code
ETA  
Date Received07/10/1997
Decision Date 08/04/1997
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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