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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 K942271
Device Name LEVEL 1* INJECT NEEDLE-FREE INJECTION SITE
Original Applicant
LEVEL 1 TECHNOLOGIES, INC.
160 weymouth st.
rockland,  MA  02370
Original Contact nancy haskins-leblanc
Regulation Number880.5440
Classification Product Code
FPA  
Date Received05/10/1994
Decision Date 07/12/1995
Decision substantially equivalent (SE)
Classification Advisory Committee General Hospital
Review Advisory Committee General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
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