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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days
510(k) Number K123734
Device Name BD NEXIVA DIFFUSICS CLOSED IV CATHETER SYSTEM
Applicant
Becton Dickinson Infusion Therapy Systems, Inc.
9450 S St.ate St.
Sandy,  UT  84070
Applicant Contact KIMBERLY GEISLER
Correspondent
Becton Dickinson Infusion Therapy Systems, Inc.
9450 S St.ate St.
Sandy,  UT  84070
Correspondent Contact KIMBERLY GEISLER
Regulation Number880.5200
Classification Product Code
FOZ  
Date Received12/05/2012
Decision Date 01/17/2013
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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