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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Prosthesis, Partial Ossicular Replacement
510(k) Number K130512
Device Name NITIFLEX STAPES PROSTHESIS, DETROIT PISTON, SKARZYNSKI PISTON, ROBERSON STAPES PROSTHESIS
Applicant
Heinz Kurz GmbH Medizintechnik
Tubinger Strasse 3
Dusslingen,  DE D-72144
Applicant Contact KRISTINA BITZER
Correspondent
Heinz Kurz GmbH Medizintechnik
Tubinger Strasse 3
Dusslingen,  DE D-72144
Correspondent Contact KRISTINA BITZER
Regulation Number874.3450
Classification Product Code
ETB  
Date Received02/27/2013
Decision Date 12/02/2013
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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