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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name pump, infusion, insulin
510(K) Number K122483
Device Name PEARL DIABETES MANAGEMENT SYSTEM
Applicant
ASANTE SOLUTIONS, INC.
352 e java dr
sunnyvale,  CA  94089
Contact robin bush
Regulation Number880.5725
Classification Product Code
LZG  
Date Received08/14/2012
Decision Date 01/03/2013
Decision substantially equivalent (SE)
Classification Advisory Committee General Hospital
Review Advisory Committee General Hospital
summary summary
Type Special
Reviewed by Third Party No
Expedited Review No
Combination Product No
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