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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 K913619
Device Name CERAVITAL MIDDLE EAR IMPLANT
Applicant
FRIEDRICHSFELD MEDIZINTECHNIK AG
47 QUAIL COURT
SUITE 301
WALNUT CREEK,  CA  94596
Applicant Contact JAMES P STOUT
Correspondent
FRIEDRICHSFELD MEDIZINTECHNIK AG
47 QUAIL COURT
SUITE 301
WALNUT CREEK,  CA  94596
Correspondent Contact JAMES P STOUT
Regulation Number874.3450
Classification Product Code
ETB  
Date Received08/13/1991
Decision Date 10/15/1991
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ear Nose & Throat
510k Review Panel Ear Nose & Throat
Type Traditional
Reviewed by Third Party No
Combination Product No
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