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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 K133573
Device Name FIAGON NAVIGATION SYSTEM
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 Received11/20/2013
Decision Date 04/30/2014
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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