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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 K043375
Device Name FISCH TITANIUM MIDDLE EAR PROSTHESES
Applicant
KARL STORZ ENDOSCOPY
600 CORPORATE POINTE
5TH FLOOR
CULVER CITY,  CA  90230 -7600
Applicant Contact YVONNE FERNANDEZ
Correspondent
KARL STORZ ENDOSCOPY
600 CORPORATE POINTE
5TH FLOOR
CULVER CITY,  CA  90230 -7600
Correspondent Contact YVONNE FERNANDEZ
Regulation Number874.3495
Classification Product Code
ETA  
Subsequent Product Code
ETB  
Date Received12/08/2004
Decision Date 01/24/2005
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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