FDA 510(k) Application Details - K150059

Device Classification Name Set, Administration, Intravascular

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510(K) Number K150059
Device Name Set, Administration, Intravascular
Applicant BECTON, DICKINSON COMPANY
1 BECTON DRIVE
FRANKLIN LAKES, NJ 07666 US
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Contact AVITAL MERL
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Regulation Number 880.5440

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Classification Product Code FPA
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Date Received 01/13/2015
Decision Date 04/28/2015
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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