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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
Device Name NAVIGATOR DELIVERY SYSTEM (NAVIGATOR DS)
Applicant
Carticept Medical, Inc.
6120 Windward Pkwy. Suite 220
Alpharetta,  GA  30005
Applicant Contact Tanya Eberle
Correspondent
Carticept Medical, Inc.
6120 Windward Pkwy. Suite 220
Alpharetta,  GA  30005
Correspondent Contact Tanya Eberle
Regulation Number880.5725
Classification Product Code
FRN  
Date Received07/25/2012
Decision Date 10/26/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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