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FDA 510(k), K141456, THE FIAGON NAVIGATION - EXTENDED INSTRUMENT SET ENT, REGISTRATIONPOINTER, VENTERAPOINTER, GUIDEWIRE, POINTERSHELL
FDA 510(k), K141456, THE FIAGON NAVIGATION - EXTENDED INSTRUMENT SET ENT, REGISTRATIONPOINTER, VENTERAPOINTER, GUIDEWIRE, POINTERSHELL
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510(K) Number: K141456
Device Name: THE FIAGON NAVIGATION - EXTENDED INSTRUMENT SET ENT, REGISTRATIONPOINTER, VENTERAPOINTER, GUIDEWIRE, POINTERSHELL
Manufacturer: DIRK MUCHA
Device Classification Name: Ear, Nose, And Throat Stereotaxic Instrument
Regulation Number: PGW
Classification Product Code: KXA
Date Received: 06/02/2014
Decision Date: 10/08/2014
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: Ear Nose & Throat
Device Name: THE FIAGON NAVIGATION - EXTENDED INSTRUMENT SET ENT, REGISTRATIONPOINTER, VENTERAPOINTER, GUIDEWIRE, POINTERSHELL
Manufacturer: DIRK MUCHA
Device Classification Name: Ear, Nose, And Throat Stereotaxic Instrument
Regulation Number: PGW
Classification Product Code: KXA
Date Received: 06/02/2014
Decision Date: 10/08/2014
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: Ear Nose & Throat
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