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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 K112616
Device Name NITIBOND STAPES PROSTHESIS, NITIPLAST STAPES PROSTHESIS
Applicant
Heinz Kurz GmbH Medizintechnik
Amstel 320-1
Amsterdam,  NL 1017AP
Applicant Contact KRISTINA BITZER
Correspondent
Heinz Kurz GmbH Medizintechnik
Amstel 320-1
Amsterdam,  NL 1017AP
Correspondent Contact KRISTINA BITZER
Regulation Number874.3450
Classification Product Code
ETB  
Date Received09/08/2011
Decision Date 02/08/2013
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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