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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 K163416
Device Name Fiagon Navigation – PointerTube Straight and PointerTube Keat
Applicant
FIAGON GMBH
HENNIGSDORF,  DE 16761
Applicant Contact DIRK MUCHA
Correspondent
HOGAN LOVELLS US LLP
3 EMBARCADERO CENTER
SUITE 1500
SAN FRANCISCO,  CA  94111
Correspondent Contact YARMELA PAVLOVIC
Regulation Number882.4560
Classification Product Code
PGW  
Date Received12/05/2016
Decision Date 02/16/2017
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Ear Nose & Throat
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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