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FDA 510(k) Application Details - K141456
Device Classification Name
More FDA Info for this Device
510(K) Number
K141456
Device Name
THE FIAGON NAVIGATION - EXTENDED INSTRUMENT SET ENT, REGISTRATIONPOINTER, VENTERAPOINTER, GUIDEWIRE, POINTERSHELL
Applicant
FIAGON GMBH
NEUENDORFSTRASSE 23B
HENNIGSDORF 16761 DE
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Contact
DIRK MUCHA
Other 510(k) Applications for this Contact
Regulation Number
More FDA Info for this Regulation Number
Classification Product Code
PGW
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More FDA Info for this Product Code
Date Received
06/02/2014
Decision Date
10/08/2014
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
NE - Neurology
Review Advisory Committee
EN - Ear, Nose, & Throat
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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