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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name set, administration, intravascular
510(k) Number K964918
Device Name NIMA NEEDLELESS INJECTIONSITE MASTER ADAPTER WITH POSIFLOW POSITIVE DISPLACEMENT FEATURE, AND I.V. SETS
Original Applicant
CRITICAL DEVICE CORP.
499 nibus st.
brea,  CA  92621
Original Contact dan hyun
Regulation Number880.5440
Classification Product Code
FPA  
Date Received12/09/1996
Decision Date 04/14/1997
Decision substantially equivalent (SE)
Classification Advisory Committee General Hospital
Review Advisory Committee General Hospital
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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