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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name accessories, pump, infusion
510(k) Number K162225
Device Name WellDoc BlueStar (WellDoc DiabetesManager System and DiabetesManager-Rx System
Applicant
WellDoc, Inc
10221 Wincopin Circle Suite 150
Columbia,  MD  21044
Applicant Contact Michele Livingston
Correspondent
WellDoc, Inc
10221 Wincopin Circle Suite 150
Columbia,  MD  21044
Correspondent Contact Danielle Dorfman
Regulation Number880.5725
Classification Product Code
MRZ  
Subsequent Product Code
LNX  
Date Received08/08/2016
Decision Date 11/22/2016
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
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