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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 K190013
Device Name WellDoc BlueStar
Applicant
WellDoc, Inc.
10221 Wincopin Circle, Suite 150
Columbia,  MD  21044
Applicant Contact Caroline York
Correspondent
WellDoc, Inc.
10221 Wincopin Circle, Suite 150
Columbia,  MD  21044
Correspondent Contact Caroline York
Regulation Number880.5725
Classification Product Code
MRZ  
Subsequent Product Code
NDC  
Date Received01/03/2019
Decision Date 11/04/2019
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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