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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Replacement, Ossicular Prosthesis, Total
510(k) Number K030492
Device Name TITANIUM OSSICULAR REPLACMENT SYSTEM
Applicant
Invotec International, Inc.
6833 Phillips Industrial Blvd.
Jacksonville,  FL  32256
Applicant Contact JEFFREY L AULL
Correspondent
Invotec International, Inc.
6833 Phillips Industrial Blvd.
Jacksonville,  FL  32256
Correspondent Contact JEFFREY L AULL
Regulation Number874.3495
Classification Product Code
ETA  
Subsequent Product Code
ETB  
Date Received02/19/2003
Decision Date 03/03/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ear Nose & Throat
510k Review Panel Ear Nose & Throat
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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