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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 K120872
Device Name ASANTE CONSET AND ASANTE COMFORT SUBCUTANEOUS INFUSION SETS FOR USE WITH ASANTE PEARL INFUSION PUMPS
Applicant
Unomedical A/S Infusion Devices
Aaholmvej 1-3
Osted, Dk-4320
Osted,  DK
Applicant Contact JOHN M LINDSKOG
Correspondent
Unomedical A/S Infusion Devices
Aaholmvej 1-3
Osted, Dk-4320
Osted,  DK
Correspondent Contact JOHN M LINDSKOG
Regulation Number880.5440
Classification Product Code
FPA  
Date Received03/22/2012
Decision Date 04/20/2012
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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