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FDA 510(k) Application Details - K160369
Device Classification Name
More FDA Info for this Device
510(K) Number
K160369
Device Name
GuideWire
Applicant
FIAGON GMBH
NEUENDORFSTR. 23 B
HENNIGSDORF 16761 DE
Other 510(k) Applications for this Company
Contact
Dirk Mucha
Other 510(k) Applications for this Contact
Regulation Number
More FDA Info for this Regulation Number
Classification Product Code
PGW
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
02/10/2016
Decision Date
03/10/2016
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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