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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 K061374
Device Name INTUITION INFUSION SETS
Applicant
UNOMEDICAL A/S
AAHOLMVEJ 1-3, OSTED
ROSKILDE,  DK DK-4000
Applicant Contact RABI GHARABLI
Correspondent
UNOMEDICAL A/S
AAHOLMVEJ 1-3, OSTED
ROSKILDE,  DK DK-4000
Correspondent Contact RABI GHARABLI
Regulation Number880.5440
Classification Product Code
FPA  
Subsequent Product Code
KZH  
Date Received05/17/2006
Decision Date 07/31/2006
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
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