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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 K141273
Device Name WELLDOC DIABETESMANAGER SYSTEM AND DIABETESMANAGER- RX SYSTE
Applicant
WELLDOC, INC
1501 SAINT PAUL STREET
SUITE 118
BALTIMORE,  MD  21202
Applicant Contact DIVYA KALLAMADI
Correspondent
WELLDOC, INC
1501 SAINT PAUL STREET
SUITE 118
BALTIMORE,  MD  21202
Correspondent Contact DIVYA KALLAMADI
Regulation Number880.5725
Classification Product Code
MRZ  
Subsequent Product Code
LNX  
Date Received05/16/2014
Decision Date 07/08/2014
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
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