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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 K051264
Device Name COMFORT AND INSET SUBCUTANEOUS INFUSION SETS FOR USE WITH ABBOTT INFUSION PUMPS
Original Applicant
UNOMEDICAL A/S
aaholmvej 2, osted
roskilde,  DK 4000
Original Contact john lindskog
Regulation Number880.5440
Classification Product Code
FPA  
Date Received05/16/2005
Decision Date 09/01/2005
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
Recalls CDRH Recalls
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