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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 K151255
Device Name Navigator Aesthetic Delivery System
Applicant
Carticept Medical, Inc.
6120 Windward Prkwy
Suite 220
Alpharetta,  GA  30005
Applicant Contact CARRIBETH RAMEY
Correspondent
Regulatory and Clinical Research Institute
5353 Wayzata Blvd. Suite 505
Minneapolis,  MN  55416
Correspondent Contact RACHEL KENNEDY
Regulation Number880.5725
Classification Product Code
FRN  
Date Received05/12/2015
Decision Date 12/30/2015
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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