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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 K122215
Model NAV-011
Device Name NAVIGATOR DELIVERY SYSTEM (NAVIGATOR DS)
Original Applicant
CARTICEPT MEDICAL, INC.
6120 windward pkwy ste 220
alpharetta,  GA  30005
Original Contact tanya eberle
Regulation Number880.5725
Classification Product Code
FRN  
Date Received07/25/2012
Decision Date 10/26/2012
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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