FDA 510(k) Application Details - K020834

Device Classification Name Introducer, Catheter

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510(K) Number K020834
Device Name Introducer, Catheter
Applicant BECTON DICKINSON INFUSION THERAPY SYSTEMS, INC.
9450 SOUTH STATE ST.
SANDY, UT 84070 US
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Contact LASLIE WOOD
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Regulation Number 870.1340

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Classification Product Code DYB
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Date Received 03/14/2002
Decision Date 06/12/2002
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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