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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 K021479
Device Name CLIP PISTON AWENGEN, MODEL# 1006 805 - 1006 861
Applicant
Heinz Kurz GmbH Medizintechnik
Amstel 320-I
Amsterdam, Nh,  NL 1017AP
Applicant Contact DAGMAR MASER
Correspondent
Heinz Kurz GmbH Medizintechnik
Amstel 320-I
Amsterdam, Nh,  NL 1017AP
Correspondent Contact DAGMAR MASER
Regulation Number874.3450
Classification Product Code
ETB  
Date Received05/08/2002
Decision Date 05/21/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ear Nose & Throat
510k Review Panel Ear Nose & Throat
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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