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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 K100434
Device Name CLAVE NEUTRON
Applicant
ICU MEDICAL, INC.
4455 ATHERTON DRIVE
SALT LAKE CITY,  UT  84123
Applicant Contact TRACY BEST
Correspondent
ICU MEDICAL, INC.
4455 ATHERTON DRIVE
SALT LAKE CITY,  UT  84123
Correspondent Contact TRACY BEST
Regulation Number880.5440
Classification Product Code
FPA  
Subsequent Product Code
KGZ  
Date Received02/16/2010
Decision Date 07/09/2010
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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