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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
510(k) Number K024056
Device Name SURESET 3.0 ML RESERVOIR, MODEL 24-103
Applicant
Applied Diabetes Research, Incorporated
28481 La Falda
Laguna Niguel,  CA  92677
Applicant Contact JAMES BARLEY
Correspondent
Applied Diabetes Research, Incorporated
28481 La Falda
Laguna Niguel,  CA  92677
Correspondent Contact JAMES BARLEY
Regulation Number880.5725
Classification Product Code
FRN  
Date Received12/09/2002
Decision Date 01/17/2003
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
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