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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 K040710
Device Name TEGO NEEDLE FREE ACCESS ACCESS DEVICE
Applicant
ICU MEDICAL, INC.
951 calle amanecer
san clemente,  CA  92673
Contact dale fairchild
Regulation Number880.5440
Classification Product Code
FPA  
Date Received03/18/2004
Decision Date 08/11/2004
Decision substantially equivalent (SE)
Classification Advisory Committee General Hospital
Review Advisory Committee General Hospital
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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