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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 K063126
Device Name DANA DIABECARE IIS
Applicant
SOOIL DEVELOPMENT CO., LTD.
5677 OBERLIN DRIVE, SUITE 101
SAN DIEGO,  CA  92121
Applicant Contact JEREMY KIM
Correspondent
SOOIL DEVELOPMENT CO., LTD.
5677 OBERLIN DRIVE, SUITE 101
SAN DIEGO,  CA  92121
Correspondent Contact JEREMY KIM
Regulation Number880.5725
Classification Product Code
LZG  
Date Received10/13/2006
Decision Date 02/02/2007
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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