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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name medical computers and software
510(k) Number K100066
Device Name DIABETESMANAGER SYSTEM, DIABETESMANAGER-RX SYSTEM MODEL VERSION 1.1
Applicant
WELLDOC, INC
1501 SAINT PAUL STREET
SUITE 118
baltimore,  MD  21202
Applicant Contact malinda peeples
Correspondent
WELLDOC, INC
1501 SAINT PAUL STREET
SUITE 118
baltimore,  MD  21202
Correspondent Contact malinda peeples
Classification Product Code
LNX  
Subsequent Product Code
MRZ  
Date Received01/11/2010
Decision Date 07/15/2010
Decision substantially equivalent (SESE)
510k Review Panel General Hospital
summary summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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