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FDA 510(k) Application Details - K143610
Device Classification Name
Catheter,Intravascular,Therapeutic,Short-Term Less Than 30 Days
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510(K) Number
K143610
Device Name
Catheter,Intravascular,Therapeutic,Short-Term Less Than 30 Days
Applicant
Becton Dickinson Infusion Therapy Systems Inc.
9450 South State Street
Sandy, UT 84070 US
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Contact
John Roberts
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Regulation Number
880.5200
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Classification Product Code
FOZ
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More FDA Info for this Product Code
Date Received
12/19/2014
Decision Date
04/09/2015
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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