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FDA 510(k) Application Details - K181202
Device Classification Name
Filter, Intravascular, Cardiovascular
More FDA Info for this Device
510(K) Number
K181202
Device Name
Filter, Intravascular, Cardiovascular
Applicant
Novate Medical Ltd.
Block 11, Galway Technology Park, Parkmore
Galway H91 VE0H IE
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Contact
Gordon Crowley
Other 510(k) Applications for this Contact
Regulation Number
870.3375
More FDA Info for this Regulation Number
Classification Product Code
DTK
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
05/07/2018
Decision Date
06/06/2018
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
CV - Cardiovascular
Review Advisory Committee
CV - Cardiovascular
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
N
Expedited Review
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