FDA 510(k) Application Details - K050207

Device Classification Name Set, Administration, Intravascular

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510(K) Number K050207
Device Name Set, Administration, Intravascular
Applicant BECTON DICKINSON INFUSION THERAPY SYSTEMS, INC.
9450 SOUTH STATE ST.
SANDY, UT 84070 US
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Contact LESLIE WOOD
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Regulation Number 880.5440

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Classification Product Code FPA
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Date Received 01/28/2005
Decision Date 04/07/2005
Decision SESE - SUBST EQUIV
Classification Advisory Committee HO - General Hospital
Review Advisory Committee HO - General Hospital
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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