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FDA 510(k) Application Details - K151497
Device Classification Name
Device, Percutaneous Retrieval
More FDA Info for this Device
510(K) Number
K151497
Device Name
Device, Percutaneous Retrieval
Applicant
MERIT MEDICAL SYSTEMS INC
PARKMORE BUSINESS PARK WEST
GALWAY IE
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Contact
MARK MULLANEY
Other 510(k) Applications for this Contact
Regulation Number
870.5150
More FDA Info for this Regulation Number
Classification Product Code
MMX
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
06/04/2015
Decision Date
07/01/2015
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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