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FDA 510(k) Application Details - K960965
Device Classification Name
Injector And Syringe, Angiographic
More FDA Info for this Device
510(K) Number
K960965
Device Name
Injector And Syringe, Angiographic
Applicant
COEUR LABORATORIES, INC.
5301 DEPATURE DR.
RALEIGH, NC 27604 US
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Contact
James M Clinton
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Regulation Number
870.1650
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Classification Product Code
DXT
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More FDA Info for this Product Code
Date Received
03/11/1996
Decision Date
09/12/1996
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
CV - Cardiovascular
Review Advisory Committee
CV - Cardiovascular
Statement / Summary / Purged Status
Statement
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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