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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 K120830
Device Name NAVIGATOR DELIVERY SYSTEM (NAVIGATOR DS)
Original Applicant
CARTICEPT MEDICAL INC
6120 windward parkway
suite 220
alpharetta,  GA  30005
Original Contact tanya eberle
Regulation Number880.5725
Classification Product Code
FRN  
Date Received03/19/2012
Decision Date 04/16/2012
Decision substantially equivalent (SE)
Classification Advisory Committee General Hospital
Review Advisory Committee General Hospital
summary summary
Type Special
Reviewed by Third Party No
Expedited Review No
Combination Product No
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