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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 K120314
Device Name WELLDOC DIABETES MANAGER SYSTEM AND DIABETES MANAGER RX SYSTEM
Original Applicant
WELLDOC, INC
1501 saint paul street
suite 118
baltimore,  MD  21202
Original Contact lauren bronich-hall
Regulation Number880.5725
Classification Product Code
MRZ  
Subsequent Product Code
LNX  
Date Received02/01/2012
Decision Date 02/24/2012
Decision substantially equivalent (SE)
Classification Advisory Committee General Hospital
Review Advisory Committee General Hospital
statement statement
Type Special
Reviewed by Third Party No
Expedited Review No
Combination Product No
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