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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 K161940
Device Name Guidewire 0.6 Single Use
Applicant
FIAGON GMBH
NEUENDORFSTR 23B
Hennigsdorf,  DE 16761
Applicant Contact Dirk Mucha
Correspondent
HOGAN LOVELLS
3 Embarcadero Center, Suite 1500
San Francisco,  CA  94111
Correspondent Contact Yarmela Pavlovic
Regulation Number882.4560
Classification Product Code
PGW  
Date Received07/14/2016
Decision Date 09/18/2016
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
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