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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name ear, nose, and throat stereotaxic instrument
510(k) Number K141456
Device Name THE FIAGON NAVIGATION - EXTENDED INSTRUMENT SET ENT, REGISTRATIONPOINTER, VENTERAPOINTER, GUIDEWIRE, POINTERSHELL
Applicant
FIAGON GMBH
NEUENDORFSTRASSE 23B
HENNIGSDORF,  DE 16761
Applicant Contact DIRK MUCHA
Correspondent
FIAGON GMBH
NEUENDORFSTRASSE 23B
HENNIGSDORF,  DE 16761
Correspondent Contact DIRK MUCHA
Regulation Number882.4560
Classification Product Code
PGW  
Date Received06/02/2014
Decision Date 10/08/2014
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Ear Nose & Throat
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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