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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Accessories, Pump, Infusion
510(k) Number K083221
Device Name AIDERA DIASEND
Applicant
Aidera AB
Medicinaregatan 8a
Goteborg,  SE SE 413 46
Applicant Contact ANDERS SONESSON
Correspondent
Aidera AB
Medicinaregatan 8a
Goteborg,  SE SE 413 46
Correspondent Contact ANDERS SONESSON
Regulation Number880.5725
Classification Product Code
MRZ  
Subsequent Product Code
NBW  
Date Received10/31/2008
Decision Date 02/03/2009
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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