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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
Original Applicant
UNOMEDICAL A/S INFUSION DEVICES
aaholmvej 1-3, osted
lejre,  DK dk-4320
Original 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
Recalls CDRH Recalls
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