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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name syringe, piston
510(k) Number K080989
Device Name UNIVERSAL VIAL ACCESS SPIKE
Applicant
ICU MEDICAL, INC
4455 ATHERTON DR.
SALT LAKE CITY,  UT  84123
Applicant Contact TRACY BEST
Correspondent
ICU MEDICAL, INC
4455 ATHERTON DR.
SALT LAKE CITY,  UT  84123
Correspondent Contact TRACY BEST
Regulation Number880.5860
Classification Product Code
FMF  
Date Received04/07/2008
Decision Date 05/02/2008
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
Recalls CDRH Recalls
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