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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 K031738
Device Name SMITHS MEDICAL INSULIN INFUSION PUMP WITH COZMONITOR GLUCOSE METER
Applicant
Smiths Medical MD, Inc.
1265 Grey Fox Rd.
St. Paul,  MN  55112
Applicant Contact RUSS DAVIES
Correspondent
Smiths Medical MD, Inc.
1265 Grey Fox Rd.
St. Paul,  MN  55112
Correspondent Contact RUSS DAVIES
Regulation Number880.5725
Classification Product Code
LZG  
Date Received06/04/2003
Decision Date 05/27/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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