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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name syringe, piston
510(k) Number K122023
Device Name MIXJECT WITH SPRAY HEAD
Original Applicant
MEDIMOP MEDICAL PROJECTS, LTD.
17 hatidhar st.
raanana,  IS 43665
Original Contact llanit goldgraber
Regulation Number880.5860
Classification Product Code
FMF  
Date Received07/11/2012
Decision Date 10/04/2012
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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