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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 K990923
Device Name TUBINGEN TITANIUM PROSTHESIS (TTP) VARIO, MODELS AERIAL 1004 010 & BELL 1002 010
Applicant
HEINZ KURZ
TUEBINGER STRASSE 3
DUSSLINGEN,  DE D-72144
Applicant Contact DAGMAR S MAESER
Correspondent
HEINZ KURZ
TUEBINGER STRASSE 3
DUSSLINGEN,  DE D-72144
Correspondent Contact DAGMAR S MAESER
Regulation Number874.3450
Classification Product Code
ETB  
Subsequent Product Code
ETA  
Date Received03/19/1999
Decision Date 03/31/1999
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
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