FDA 510(k) Application Details - K111366

Device Classification Name Catheter,Intravascular,Therapeutic,Short-Term Less Than 30 Days

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510(K) Number K111366
Device Name Catheter,Intravascular,Therapeutic,Short-Term Less Than 30 Days
Applicant BECTON DICKINSON AND COMPANY (BD)
9450 SOUTH STATE STREET
SANDY, UT 84070 US
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Contact RACHEL LEBLANC
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Regulation Number 880.5200

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Classification Product Code FOZ
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Date Received 05/16/2011
Decision Date 09/30/2011
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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