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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 K010442
Device Name KURZ ANGULAR PISTON-TITANIUM PROSTHESIS, MODELS 1006 600, 1006 601, 1006 602, 1006 650, 1006 651, 1006 652
Applicant
Heinz Kurz
Amstel 320-I
Amsterdam 1017ap,  NL
Applicant Contact DAGMAR S MASER
Correspondent
Heinz Kurz
Amstel 320-I
Amsterdam 1017ap,  NL
Correspondent Contact DAGMAR S MASER
Regulation Number874.3450
Classification Product Code
ETB  
Date Received02/14/2001
Decision Date 03/08/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ear Nose & Throat
510k Review Panel Ear Nose & Throat
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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