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FDA 510(k) Application Details - K150473
Device Classification Name
More FDA Info for this Device
510(K) Number
K150473
Device Name
FlexPointer 1.5 mm
Applicant
FIAGON GMBH
NEUENDORFSTR. 23B
HENNIGSDORF 16761 DE
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Contact
DR. DIRK MUCHA
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Regulation Number
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Classification Product Code
PGW
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More FDA Info for this Product Code
Date Received
02/23/2015
Decision Date
04/16/2015
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
NE - Neurology
Review Advisory Committee
EN - Ear, Nose, & Throat
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
N
Expedited Review
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