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FDA 510(k) Application Details - K140608
Device Classification Name
Wire, Guide, Catheter
More FDA Info for this Device
510(K) Number
K140608
Device Name
Wire, Guide, Catheter
Applicant
MERIT MEDICAL SYSTEMS, INC.
PARKMORE BUSINESS PARK WEST
GALWAY EI IE
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Contact
SIOBHAN KING
Other 510(k) Applications for this Contact
Regulation Number
870.1330
More FDA Info for this Regulation Number
Classification Product Code
DQX
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
03/10/2014
Decision Date
09/12/2014
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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