FDA 510(k) Application Details - K172204

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

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510(K) Number K172204
Device Name Catheter,Intravascular,Therapeutic,Short-Term Less Than 30 Days
Applicant Becton, Dickinson and Company
9450 South State Street
Sandy, UT 84070 US
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Contact Henry Boland
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Regulation Number 880.5200

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Classification Product Code FOZ
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Date Received 07/21/2017
Decision Date 08/17/2017
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 Y
Expedited Review



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