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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Stopcock, I.V. Set
510(k) Number K082836
Device Name ICU MEDICAL UNIVERSAL SINGLE-USE SPIKES
Applicant
ICU MEDICAL, INC.
4455 ATHERTON DRIVE
SALT LAKE CITY,  UT  84123
Applicant Contact NILOUFAR SAMIMI
Correspondent
ICU MEDICAL, INC.
4455 ATHERTON DRIVE
SALT LAKE CITY,  UT  84123
Correspondent Contact NILOUFAR SAMIMI
Regulation Number880.5440
Classification Product Code
FMG  
Date Received09/26/2008
Decision Date 02/25/2009
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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