FDA 510(k) Application Details - K181718

Device Classification Name Set, Administration, Intravascular

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510(K) Number K181718
Device Name Set, Administration, Intravascular
Applicant Becton, Dickinson and Company
1 Becton Drive
Franklin Lakes, NJ 07417 US
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Contact Meriam Youssef
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Regulation Number 880.5440

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Classification Product Code FPA
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Date Received 06/29/2018
Decision Date 10/18/2018
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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