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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 K992839
Device Name SOCKET STAPES PISTON W/O LOOP, SCHOBEL, SCHOBEL-CAUSSE
Applicant
HEINZ KURZ GMBH MEDIZINTECHNIK
AMSTEL 320-I
AMSTERDAM,  NL 1017 AP
Applicant Contact DAGMAR S MAESER
Correspondent
HEINZ KURZ GMBH MEDIZINTECHNIK
AMSTEL 320-I
AMSTERDAM,  NL 1017 AP
Correspondent Contact DAGMAR S MAESER
Regulation Number874.3450
Classification Product Code
ETB  
Date Received08/23/1999
Decision Date 09/16/1999
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
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