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FDA 510(k) Application Details - K161940
Device Classification Name
More FDA Info for this Device
510(K) Number
K161940
Device Name
Guidewire 0.6 Single Use
Applicant
FIAGON GMBH
NEUENDORFSTR 23B
Hennigsdorf 16761 DE
Other 510(k) Applications for this Company
Contact
Dirk Mucha
Other 510(k) Applications for this Contact
Regulation Number
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Classification Product Code
PGW
Other 510(k) Applications for this Device
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Date Received
07/14/2016
Decision Date
09/18/2016
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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