FDA 510(k) Application Details - K113133

Device Classification Name Injector And Syringe, Angiographic

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510(K) Number K113133
Device Name Injector And Syringe, Angiographic
Applicant MEDRAD, INC.
ONE MEDRAD DRIVE
INDIANOLA, PA 15051 US
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Contact MIKE BURNSIDE
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Regulation Number 870.1650

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Classification Product Code DXT
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Date Received 10/24/2011
Decision Date 12/15/2011
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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