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FDA 510(k) Application Details - K163084
Device Classification Name
Injector And Syringe, Angiographic
More FDA Info for this Device
510(K) Number
K163084
Device Name
Injector And Syringe, Angiographic
Applicant
Merit Medical Systems, Inc.
1600 West Merit Parkway
South Jordan, UT 84095 US
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Contact
Cory Marsh
Other 510(k) Applications for this Contact
Regulation Number
870.1650
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Classification Product Code
DXT
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
11/03/2016
Decision Date
06/15/2017
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
CV - Cardiovascular
Review Advisory Committee
CV - Cardiovascular
Statement / Summary / Purged Status
Summary
Type
Abbreviated
Reviewed By Third Party
N
Expedited Review
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