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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 K062323
Device Name DELTEC COZMO INSULIN INFUSION PUMP WITH COZMONITOR BLOOD GLUCOSE METER, MODELS 21-1815, 21-1816, 21-1817
Applicant
SMITHS MEDICAL MD, INC.
1265 GREY FOX RD.
ST. PAUL,  MN  55112
Applicant Contact DAVID H SHORT
Correspondent
SMITHS MEDICAL MD, INC.
1265 GREY FOX RD.
ST. PAUL,  MN  55112
Correspondent Contact DAVID H SHORT
Regulation Number880.5725
Classification Product Code
LZG  
Date Received08/09/2006
Decision Date 11/01/2006
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
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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