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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 K112370
Device Name WELLDOC DIABETES MANAGER SYSTEM AND DIABETES MANAGER RX SYSTEM
Applicant
WELLDOC, INC
1501 SAINT PAUL STREET
SUITE 118
baltimore,  MD  21202
Applicant Contact lauren bronich-hall
Correspondent
WELLDOC, INC
1501 SAINT PAUL STREET
SUITE 118
baltimore,  MD  21202
Correspondent Contact lauren bronich-hall
Regulation Number880.5725
Classification Product Code
MRZ  
Subsequent Product Code
LNX  
Date Received08/17/2011
Decision Date 10/14/2011
Decision substantially equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
statement statement
Type Special
Reviewed by Third Party No
Combination Product No
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