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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Set, Administration, Intravascular
510(k) Number K012429
Device Name SURESET INFUSION SET, MODEL 8023
Applicant
Applied Diabetes Research, Incorporated
103 Nolen Ln.
Chapel Hill,  NC  27516
Applicant Contact CHARLES H KYPER
Correspondent
Applied Diabetes Research, Incorporated
103 Nolen Ln.
Chapel Hill,  NC  27516
Correspondent Contact CHARLES H KYPER
Regulation Number880.5440
Classification Product Code
FPA  
Date Received07/31/2001
Decision Date 11/06/2001
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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