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FDA 510(k) Application Details - K140469
Device Classification Name
Injector And Syringe, Angiographic
More FDA Info for this Device
510(K) Number
K140469
Device Name
Injector And Syringe, Angiographic
Applicant
COEUR, INC.
100 PHYSICIANS WAY
SUITE 200
LEBANON, TN 37090 US
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Contact
ERIN RHEINSCHELD
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
02/25/2014
Decision Date
07/28/2014
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
CV - Cardiovascular
Review Advisory Committee
CV - Cardiovascular
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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