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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Pump, Infusion
510(k) Number K861007
Device Name BECTON DICKINSON PCAINFUSER
Applicant
Bd Becton Dickinson Vacutainer Systems Preanalytic
Mack Centre Dr.
P.O.Box 2224
Paramus,  NJ  07652
Applicant Contact R. J ARNSBERGER
Correspondent
Bd Becton Dickinson Vacutainer Systems Preanalytic
Mack Centre Dr.
P.O.Box 2224
Paramus,  NJ  07652
Correspondent Contact R. J ARNSBERGER
Regulation Number880.5725
Classification Product Code
FRN  
Date Received03/18/1986
Decision Date 05/20/1986
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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