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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
LEJRE,  DK DK-4320
Applicant Contact JOHN M LINDSKOG
Correspondent
UNOMEDICAL A/S INFUSION DEVICES
AAHOLMVEJ 1-3, OSTED
LEJRE,  DK DK-4320
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
Recalls CDRH Recalls
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