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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 K100576
Device Name HIGH PRESSURE SETS-400 PSI
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  
Date Received03/01/2010
Decision Date 12/17/2010
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
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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